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

Catalog Number 5C4474

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problems Electric Shock (2554); No Known Impact Or Consequence To Patient (2692)

Event Date 08/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a person felt an electric shock when touching a homechoice device.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation and an evaluation is complete.A device history review revealed no issues that could have caused or contributed to the reported issue.The reported problem was not identified during the event history log review.Internal and external inspection was performed and no issues were noted.Functional tests were performed with no issues noted.A short simulated therapy was successfully performed.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• Manufacturer (Section G): BAXTER HEALTHCARE - SWINFORD; 2 woodlands industrial park d; singapore ; SN
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5973463
• MDR Text Key: 55475494
• Report Number: 1416980-2016-15578
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• 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: 09/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/11/2016
• 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