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

Catalog Number 5C4474

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint no: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced an electrical current from a homechoice device during use.This occurred during dwell one of five of peritoneal dialysis therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was received for evaluation.Internal and external inspection was performed and no issues were noted.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.The device was determined to meet functional and electrical performance specification requirements per rite testing.A short simulated therapy was successfully performed.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported issue of an electric shock was not verified and the cause of the condition could not be determined.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 - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5074606
• MDR Text Key: 25672609
• Report Number: 1416980-2015-35794
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2015
• 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