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

Catalog Number 5C5479

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2020

Event Type  malfunction  

Manufacturer Narrative

The device was discarded; 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 an amia automated pd cycler set with cassette leaked.This was further described as ¿after completing therapy they went to remove the cassette from the cartridge, after removal they noticed a small crack and solution leaking out of the bottom left cormer of the cassette¿.No leaks or issues were noticed before or during the therapy.The patient received prophylactic antibiotics as a precaution.There was no patient injury associated with this event.No additional information is available.

Manufacturer Narrative

Additional information: h6.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was discarded; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: AMIA AUTOMATED PD CYCLER SET
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10102217
• MDR Text Key: 193015322
• Report Number: 1416980-2020-03012
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412153186
• UDI-Public: (01)00085412153186
• Combination Product (y/n): N
• PMA/PMN Number: K151525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: 5C5479
• Device Lot Number: H20D01097
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1