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

Catalog Number 5C4471

Device Problem Unintended Electrical Shock (4018)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.During evaluation, the device turned on and worked correctly, the reported problem was not duplicated.The device did not present any electrical problems, nor were any damaged components or parts identified that could have caused or contributed to the reported problem.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the electrical impulses.The manufacturing record review was performed and no issues were found during the prior servicing related to the reported event.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a jolt was felt by the patient while performing peritoneal dialysis (pd) therapy with a homechoice automated pd system.The patient felt electrical impulses in the chest and abdomen while laying on their back.This occurred during dwell one of nine.The patient sleeps in a rocking chair (metal), which it fills with pillows so that the patient is upright, and the patient's feet (without footwear) are placed on a chair (metal).Therapy was discontinued and the patient drained manually.Patient did not notice any defects in the power cord or moisture around the device.There was no 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 - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15259989
• MDR Text Key: 298246255
• Report Number: 1416980-2022-04346
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• 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: 08/03/2022
• Date Manufacturer Received: 07/27/2022
• 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: Initial
• Patient Sequence Number: 1