Baxter AMIA Automated Peritoneal Dialysis System Software Recall
Baxter is recalling 7,688 AMIA Automated Peritoneal Dialysis Systems due to a software defect that may cause shortened dwell times during therapy.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a software defect that may lead to suboptimal treatment (shortened dwell times), representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
Baxter Healthcare Corporation is recalling 7,688 AMIA Automated Peritoneal Dialysis Systems. The recall is due to a potential software defect on the automated peritoneal dialysis system cyclers that can cause shortened dwell times during a Cycle-Based therapy.
The affected devices are intended for the automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing peritoneal dialysis. The recall includes all serial numbers for devices distributed from February 11, 2016, through November 27, 2018.
The devices were distributed nationwide in the United States and internationally to Canada and Japan. Patients using these devices should contact their healthcare provider or Baxter Healthcare Corporation for instructions on how to proceed with their treatment.
The recalled product
- Product
- AMIA Automated Peritoneal Dialysis System Product Usage: It is intended for automatic control of dialysate solution exchanges in the treatment of adult renal failure patients undergoing Peritoneal dialysis.
- Manufacturer
- Baxter Healthcare Corporation
- Affected units
- 7,688
Distribution
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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