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

Catalog Number 5C8310

Device Problems Grounding Malfunction (1271); Device Emits Odor (1425)

Patient Problems No Consequences Or Impact To Patient (2199); Electric Shock (2554)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a home patient (hp) experienced electric shock from the homechoice during peritoneal dialysis therapy.The hp was connected.The hp stated that for the last few months, had felt through something was going through the body like was being shocked and it was concentrated around the neck area.The hp also stated that the caregiver (cg) noticed that the cord on the ground where it plugs into the large extension cord was burning the carpet.Hp stated about feeling warmer than usual in the past, especially around the neck, but the feeling of electric shock really only happened last night and the damage to the carpet was done the night before.Hp mentioned that the homechoice does smell like burning metal.Renal therapy services (rts) agent advised the hp to inform the registered nurse about the incident and missed therapy.Rts initiated a swap and discussed continuous peritoneal ambulatory peritoneal dialysis.Seven days after the event, it was confirmed that the patient was not cleaning the device when electric shock was felt.The patient was asked how he usually cleaned the device to check for use error.The patient stated that semi-moist paper cloths are used, and alcohol use was excluded.The patient confirmed to be wearing footwear (indoor slippers) and no woolly attire during pd therapy.A 3-prong-plug was used with the device, with one of the pins (possibly the earth pin, according to the patient) described to be ¿completely destroyed¿.The electrical extension cord was 10 feet long.The burning issue involving the electrical cord and the carpet had been noticed by the patient¿s wife on previous occasions.The patient admitted to have ignored the wife.The patient¿s house was described to be adequately grounded.At the time of the event, there was no excessive cold temperatures necessitating the use of house-warming devices.The patient described the reaction to the electrical event as ¿warmth in the body concentrating at the back of the neck; the nape felt extra warm and scratchy¿.No visible burns were sustained and the patient did not seek medical assistance.The neck irritation was still present at the time of this report.There was no patient injury and no medical intervention reported at the time of the event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.A visual inspection was performed with naked eye with no issues 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.All voltages were within specifications.The sample analysis was performed and there was no device malfunction found that could have caused or contributed to the reported problems.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.This type of event would not be noted in the event history log.The reported problem was not verified.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• 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: 7639558
• MDR Text Key: 112452336
• Report Number: 1416980-2018-03891
• 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: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR