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

Catalog Number 5C5479

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The incidents occurred on a unreported date in (b)(6) 2018.The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that sixteen (16) amia cassettes were damaged.The damage was further described as the sheeting was "pulled up" from the cassettes.This was noticed during set up of peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Five (5) samples out of sixteen (16) were received for evaluation.A visual inspection was performed with naked eye with no issues noted.Functional testing including leak testing, clear passage testing and clamp function testing were performed with no issues noted.The reported condition was not verified on the returned samples.Eleven (11) devices were not received for evaluation; therefore, a device analysis could not be completed on those samples.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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 - MOUNTAIN HOME; mountain home AR
• 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: 8026602
• MDR Text Key: 125758555
• Report Number: 1416980-2018-06993
• Device Sequence Number: 1
• Product Code: FKX
• UDI-Device Identifier: 00085412153186
• UDI-Public: (01)00085412153186
• Combination Product (y/n): N
• 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,Followup
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/10/2020
• Device Catalogue Number: 5C5479
• Device Lot Number: H18D10050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 11/02/2018
• Supplement Dates FDA Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1