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

Catalog Number 5C4471R

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problem Shock (2072)

Event Type  malfunction  

Event Description

It was reported that the patient got shocked when it rained, coincident with automated peritoneal dialysis (apd) therapy on the homechoice machine.There was no patient injury or medical intervention indicated at the time of the report.No additional information is available.

Manufacturer Narrative

(b)(4).Actual occurrence date and therapy date are unknown.The device was received for analysis and the evaluation is pending conclusion.Should additional relevant information become available, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).The device was returned to baxter, and the evaluation is complete.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.No abnormalities were identified during internal/external inspections.The device passed both electrical and functional returned instrument testing evaluation (rite) tests.The device powered up properly.All power supply voltages were within specification limits.Resistance and voltage measurements were performed on all exposed metals on the hc device with no issues noted.There was no evidence of fluid residue on the hc device and all hardware was secure.The service history record showed no previous service events were the same/similar to the reported problem.The reported electrical shock was unable to be verified or duplicated during sample analysis as no non-conforming product was noted.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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3840590
• MDR Text Key: 4618176
• Report Number: 1416980-2014-17381
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4471R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2014
• Initial Date FDA Received: 05/30/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/18/2014
• 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