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

Catalog Number 5C4471

Device Problem Grounding Malfunction (1271)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a homechoice presented an electric shock.The issue occurred at the end of the therapy.The patient was not connected at the time of the event.The patient stated that they were taking the cassette out when the issue happened.Continuous ambulatory peritoneal dialysis was discussed.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.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.Internal and external inspection was performed and no issues were noted.The device passed both the (b)(4) (return instrument test/evaluation) electrical testing and the (b)(4) functional testing.The device was determined to meet performance specification requirements per (b)(4) testing.All ac voltage measurements indicated a resistance of less than 1 ohm.The reported condition not was 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 - LARGO; largo FL
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7356917
• MDR Text Key: 103036207
• Report Number: 1416980-2018-01486
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• 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,Followup
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2018
• 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
• Patient Age: 31 YR