MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AMIA AUTOMATED PD CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C5479

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced air in the patient line of an amia automated pd set with cassette.This was identified during the initial drain of peritoneal dialysis (pd) therapy.The home patient (hp) was connected at the time of the event.The hp observed multiple air gaps that were over 1/8th of an inch each; further described as ¿at least three air gaps in the patient line¿.Renal therapy services (rts) assisted the hp to end the therapy early and advised the hp to contact their peritoneal dialysis registered nurse regarding the issue.Rts reviewed proper procedures per the user manual with the hp and advised the device was ready to be set up with new supplies.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: AMIA AUTOMATED PD CYCLER SET
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10326829
• MDR Text Key: 200436835
• Report Number: 1416980-2020-04329
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K151525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C5479
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: AMIA AUTOMATED PD SYSTEM