MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HOMECHOICE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C4474

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/18/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).The device was received for evaluation.Visual inspection revealed that the power cord was damaged.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was verified.The cause of the customer reported condition was determined to be the defective power cord.The power cord was replaced to resolve the issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the cable attached to the back of a homechoice device was on fire.This occurred during the last cycle of peritoneal dialysis therapy.The reporter further stated that the cable appeared to be melted.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: HOMECHOICE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9964615
• MDR Text Key: 187790831
• Report Number: 1416980-2020-02190
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5C4474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2020
• Date Manufacturer Received: 03/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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