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

Catalog Number 5C5479

Device Problems Fluid/Blood Leak (1250); Material Perforation (2205)

Patient Problem Injury (2348)

Event Date 08/30/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an amia automated peritoneal dialysis set with cassette leaked fluid from a hole in the tubing.The caregiver stated that the solution leaked out and onto the floor.The cause of the perforated tubing was unknown.The patient was brought to the hospital and was administered prophylactic antibiotics.No further medical intervention was reported for this event.Patient outcome was not reported.No additional information is available.

Manufacturer Narrative

Upon review, it was noted there was no report of hospital admission and the antibiotic treatment was for precautionary measures, therefore, the amia apd set with cassette is no longer considered suspect in this event.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

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 not received for evaluation; 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 - 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: 7902586
• MDR Text Key: 121490544
• Report Number: 1416980-2018-06118
• 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,Followup
• Report Date: 10/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/17/2020
• Device Catalogue Number: 5C5479
• Device Lot Number: H18E17102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 09/24/2018
• Supplement Dates Manufacturer Received: 09/28/2018; 10/12/2018
• Supplement Dates FDA Received: 10/04/2018; 10/24/2018
• 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: N
• Patient Sequence Number: 1
• Treatment: AMIA AUTOMATED PD SYSTEM
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR