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); Protective Measures Problem (3015)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

An alarm indicative of a potential malfunction of the disposable set was reported.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.However, a leak was reported from the heater bag line of the amia cassette, which is known to cause this alarm.The cause of the leak could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a low priority 30166 (max air exceeded) alarm occurred on an amia automated pd system during peritoneal dialysis therapy.This alarm occurred during fill four while the patient was connected.During troubleshooting, it was discovered that there was leak from the heater bag line of an amia cassette set.No damage noted on the heater bag.To resolve the issue, the patient started therapy over with new supplies.Renal therapy services (rts) reviewed proper procedures per the user manual with the patient.Continuous ambulatory peritoneal dialysis was discussed.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 - 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: 8848710
• MDR Text Key: 152908768
• Report Number: 1416980-2019-04215
• Device Sequence Number: 1
• Product Code: FKX
• 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
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• 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: 07/05/2019
• 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