MAUDE Adverse Event Report: BAXTER HEALTHCARE - ROUND LAKE AMIA AUTOMATED PD SYSTEM COUNTRY KIT; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C6010

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/09/2019

Event Type  malfunction  

Manufacturer Narrative

The power cord device was not returned, and the serial number is unknown; therefore, a device analysis could not be completed; however, the amia automated peritoneal dialysis (pd) system was returned for evaluation.An external / internal inspection of the returned amia was performed and found no evidence of damage caused by a power cord fire.There was no smell of smoke inside or outside of the device.The contacts of the power entry module (power cord connection) were inspected and no arching marks were found which would be an indication of an overheating condition.The main power fuse was inspected and found no issues.The main power fuse was of the correct amperage as well.The device was powered up successfully without any alarms.A short-simulated therapy was completed and passed without any delays or alarms.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the power cable of an amia automated peritoneal dialysis (pd) system caught fire and melted.This event occurred during an unspecified process step while the patient was connected for pd therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: AMIA AUTOMATED PD SYSTEM COUNTRY KIT
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE ¿ ROUND LAKE; 25212 w. illinois route 120; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8876558
• MDR Text Key: 153781655
• Report Number: 1416980-2019-04344
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• 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: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C6010
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/10/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1