Spectrum IQ Infusion Pumps - recalled due to Multiple Connectivity Errors, USA

2 years ago source www.fda.gov

Recall notice

United States

Company name: Baxter International Inc.
Brand name: Spectrum IQ
Product recalled: Infusion Pumps
Reason of the recall: Multiple Connectivity Errors
FDA Recall date: August 24, 2021
Recall details: Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for all Spectrum IQ infusion pumps to reinforce important safety information when customers implement changes to their network configuration and server systems. Baxter previously communicated this information to customers via an Urgent Medical Device Correction notification on June 4, 2021 and a follow-up communication with updated information on August 2, 2021.

Two Spectrum IQ infusion pump customers notified Baxter of system errors occurring in multiple pumps within their fleets following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in multiple pump connectivity errors, placing stress on the pump’s processor. When this occurs, pumps initiate a “watchdog” system error alarm to notify the user of the issue, causing the pump to enter a fail-safe mode which stops all pump processes, including delivery of fluid to the patient. For both customers, the watchdog system errors were resolved by restoring network and server system performance to expected levels.

- Spectrum IQ Infusion System with Dose IQ Safety Software. Product Code: 3570009. Serial Numbers: All

To date, there have been no reports of adverse events or patient injury associated with this issue. However, depending on several factors, such as the length of delay, medication being infused, the volume and rate of the infusion, patient status, and comorbidities, the patient may experience serious adverse health consequences or death. Baxter is developing a software upgrade for all Spectrum IQ infusion pumps that will assist how the pump responds to unstable network and server systems by reducing the stress on the pump’s memory and processing functions if this occurs.

The updated software is currently expected to be available early in the fourth quarter of 2021, and Baxter will work with customers to schedule the software upgrades. To reduce the likelihood of encountering this issue, Baxter is asking customers to contact Baxter Technical Assistance at 800-356-3454 in advance of making changes to their network or server infrastructure supporting the pumps or the Baxter Gateway. Changes requiring prior notice can be found in the Urgent Medical Device Correction communication and in Baxter’s Gateway Server Installation Handoff document, which customers receive upon installation. Additionally, Baxter recommends that customers ensure backup devices are readily available when infusing critical medications.

Customers with additional questions can contact their Baxter sales representative or Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday through Friday between 6 a.m. and 6 p.m. Central Time. Baxter is voluntarily issuing this Urgent Medical Device Correction with the knowledge of the U.S. Food and Drug Administration.

Check the full recall details on www.fda.gov

Source: FDA

#medicaldevices #recall #us

Recent Interesting Reports

Y
Toptorches. com, 192-01 Nothern Blvd, Flushing, NY 11358, USA sold me two rechargeable tesla coil lighters for $74, received the lighters on 4/21/24 only to find they are cheap butane lighters made in China. This looks to be a scam. Order Number 317****, and Order Number 317****.

#scam #onlineshopping #delivery #onlinescam #newyork #us

J

Scam, Saskatchewan, Canada

5 days ago reported by user-jczyy898

I submitted a report about a hydrogen bottle that did not have an outlet for a plug in.
I ordered a hydrogen bottle from YW Co. Ltd, from Mississauga, ON. and there is no outlet on the bottom of the bottle for any plug in. I emailed … See More
about the problem and they sent another plug in for the unit, but there no outlet for a plug in. I want a refund.
See Less

#scam #onlineshopping #delivery #onlinescam #saskatchewan #ca

K
I ordered an item (natural horseshoe cross) from this company. When it arrived, it looked nothing like the beautiful picture. It's cheap plastic and you have to put it together yourself. This company or person needs to be investigated. I received emails about the item shipping from … See More
Poland, but the box it came in has a New York address. It took 6 weeks to arrive and is nothing but a piece of junk!
See Less

#scam #onlineshopping #delivery #onlinescam

C
Had an item shipped on 3/18/24 from MA to my home in NJ. It's been stuck in Teterboro for a week and a half. Either it was stolen or lost. Neither of which is acceptable. I was actually told by two different postal employees there is a … See More
HUGE theft issue at that location. This is why UPS and FedEx are both doing a bang up business. Meanwhile, the state and federal governments expect us to have trust when we use absentee ballots for elections. What a total joke.
#uspostalservice #200industrialavenue #teterboro #newjersey #us #usps
See Less

#uspostalservice #200industrialavenue #teterboro #newjersey #us

ADM Animal Nutrition announced that specific lots may contain elevated levels of calcium, phosphorus, magnesium, sodium and/or chloride and may harm chickens, swine, beef cattle and equine. ADM (NYSE: ADM), is recalling the following products: Pen Pals® Chicken Starter-Grower 25-lb bag (Product No 70009ACF46); Pen Pals Chicken … See More
Starter-Grower 50-lb bag (Product No. 70009AAA44); Pen Pals Chicken Starter-Grower 25-lb case (Product No. 70009AAABE); MoorMan’s ShowTec Sale Burst w/DF DEN 50-lb. bag (Product No 21256CVWE4); MoorMan's Show-Tec Burst Starter with DFCTC/DEN 50-lb. bag (Product No: 24320AYWE4); ShowTec BB 18 BMD 50-lb. bag (Product No. 18241AGNE4); ShowTec 14.5/6 BMD 50-lb. bag (Product No. 14560AGN); AMPT-A CTC/IGR 50-lb. bag (Product No. 54229XNK); ShowTec Hi Fat 18 BMD 50-lb. bag (Product No. 18007AGN); Seniorglo 50-lb. bag (Product No. 10130AB) and MotivAte 12-15 DEN 50-lb. bag (Product No. 12286CVW). One customer reported chicken deaths related to consumption of the Pen Pals Chicken Starter-Grower 25-lb bags.

The lot number for the Pen Pals Chicken Starter-Grower 25-lb bags involved in this recall is Lot 507650QN. This product may contain elevated levels of calcium and phosphorus, which could lead to leg deformities, trouble standing and walking, and can be fatal to chickens. This product was distributed between Feb. 29, 2024 and March 8, 2024, and could have been purchased through distributors in Iowa and Missouri.

The lot number for the Pen Pals Chicken Starter-Grower 50-lb bags and Pen Pals® Chicken Starter-Grower 25-lb case involved in this recall is Lot 506942QN. These products may contain elevated levels of magnesium, which can cause bone deformities, slow growth rate, watery feces and can be fatal to chickens. These products were distributed between Feb. 28, 2024 and March 14, 2024, and could have been purchased through distributors in Missouri, Ohio, South Carolina, Iowa, California and Oregon.

The lot number for the MoorMan’s ShowTec Sale Burst w/DF DEN 50-lb. bags involved in this recall is Lot 506664QN. This product may contain increased levels of sodium and chloride, which can lead to reduced feed intake, thirst and diarrhea. This product was distributed between Feb. 16, 2024, and March 1, 2024, and could have been purchased through distributors in Iowa, Wisconsin and Colorado.

The lot number for the MoorMan’s ShowTec Burst Starter w/DF CTC/DEN 50-lb. bags involved in this recall is Lot 506640QN. This product may also contain increased levels of sodium and chloride. This product was distributed between Feb. 16, 2024, and March 1, 2024, and could have been purchased through distributors in Iowa, Wisconsin and Colorado.

The lot number for the ShowTec BB 18 BMD 50-lb. bags involved in this recall is Lot 506939QN. This product may also contain increased levels of sodium and chloride. This product was distributed between Feb. 16, 2024, and March 1, 2024, and could have been purchased through distributors in California, Illinois, Arizona, Missouri, and Iowa. The lot number for the ShowTec 14.5/6 BMD 50-lb. bags involved in this recall is Lot 507900QN. This product may contain increased levels of calcium, which could cause reduced feed intake and feed conversion. This product was distributed between March 8, 2024, and March 18, 2024, and could have been purchased through distributors in Iowa.

The lot number for the AMPT-A CTC/IGR 50-lb. bags involved in this recall is Lot 507828QN. This product may contain increased levels of sodium, which could cause loose stools and central nervous system issues. This product was distributed on March 1, 2024, and could have been purchased through distributors in Missouri.

The lot number for the ShowTec Hi Fat 18 BMD 50-lb. bags involved in this recall is Lot 505791QN. This product may contain increased levels of magnesium and calcium, which could cause reduced feed intake and feed conversion. This product was distributed between Jan. 26, 2024, and Feb. 7, 2024, and could have been purchased through distributors in Iowa, Oregon and California.

The lot number for the Seniorglo 50-lb. bags involved in this recall is Lot 505426QN. This product may contain increased levels of calcium, which could cause weight loss and the animal to become weak and listless. This product was distributed between Jan. 24, 2024, and Feb. 1, 2024, and could have been purchased through distributors in Missouri, Illinois, Ohio, Tennessee as well as from ADM locations in Glencoe, Minn., Springfield, Mo. and Dublin, Texas.

The lot number for the MotivAte 12-15 DEN 50-lb. bags involved in this recall is Lot 507330QN. This product may contain increased levels of calcium and phosphorus, which could cause reduced feed intake and feed conversion This product was distributed on Feb. 27, 2024, and March 4, 2024, and could have been purchased from ADM locations in Glencoe, Minn. and Columbus, Neb. After receiving a customer complaint related to swine refusing to eat feed from a single lot of MoorMan’s ShowTec Sale Burst w/DF DEN, ADM immediately investigated and discovered that the company’s animal feed manufacturing facility in Quincy, Illinois, experienced an equipment failure issue that impacted ingredient distribution in the plant.

The company initiated the recall once it was confirmed that these specific lots could contain harmful levels of calcium, phosphorus, magnesium sodium, and/or chloride. ADM has been in direct contact with the customers and distributors involved in this recall, and all product has been removed from retail shelves.

The lot number can be found at the bottom of the label. Customers who have purchased the recalled feed should immediately stop using it and return it to their distributor or directly to ADM Animal Nutrition for a full refund.

Company name: ADM Animal Nutrition
Brand name: Multiple Brand Names
Product recalled: Chicken Feed, Swine Feed, Cattle Feed, Horse Feed
Reason of the recall: Specific lots may contain elevated levels of calcium, phosphorus, magnesium, sodium and/or chloride and may harm chickens, swine, beef cattle and equine.
FDA Recall date: April 01, 2024

Source: www.fda.gov
See Less

#recall #petfood #us

Create a Report

Please provide report title
Please provide location
Please provide details

Get alerts and updates for your case!

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

Please provide email or phone
Please provide email or phone

We do not show your email or contact info

Skip this step

Add photos or video

We recommend photos and videos to help explain your report

Add Photo/Video
Skip this step

Email or SMS copy of report

Enter below to get emailed a copy of your report, or sms a link to your report

Please provide email or phone
Please provide email or phone

Thank you for your report!


IMPORTANT - Your report is queued
It may take up to 12 hours to process your report.


Email us at support@safelyhq.com if you have questions.

Report by

Please provide location
Please provide location
Please provide report title
Please provide details
Please accept our Terms & Conditions
Get alerts and updates for your case! Your contact information is not shown on the website.

This information is not shown on the website. We can notify you of updates, and may contact you for more information to help resolve or follow up on your issue.

or
Please provide email or phone
Thank you for your report!

IMPORTANT - YOUR REPORT IS QUEUED - IT MAY TAKE UP TO 12 HOURS FOR YOUR REPORT TO SHOW ON OUR HOME PAGE (IF NOT OPTED AS PRIVATE)

Visit our learn pages for more helpful information or, email us: support@safelyhq.com

Goodbye! and best wishes in your recovery
Last 30 days