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 08/22/2023

Event Type  malfunction  

Manufacturer Narrative

H10: the device was received for evaluation.During internal and external visual inspection, the elbow fitting, valve manifold (3 way), inner door gasket and assy cable digital were observed damaged.The device was powered on and the reported issue was not duplicated.The reported condition was not verified.The damaged components did not contribute with the reported issue or in connection with the reported problem.The damaged components were replaced.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported during the dwell phase of peritoneal dialysis therapy with a homechoice automated pd system the patient felt a ¿small electric shock in the stomach¿ while laying down.The patient visited the doctor and was told ¿the patient was in good health¿.The device had been plugged directly into a grounded outlet with no power cord defect.The patient cleaned and disinfected the machine with "a solution of water and chlorine and dry cloth".The patient was not touching any other device with electrical voltage.No footwear was worn at the time of the event.No signs of burns were noted to the machine.There was no report of patient injury or 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 - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17777532
• MDR Text Key: 323800513
• Report Number: 1416980-2023-04725
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4471
• Device Lot Number: 672465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2023
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1