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

Catalog Number R5C8320

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2015

Event Type  malfunction  

Event Description

It was reported that a patient experienced an electric shock during set-up of a homechoice device.The patient did not sustain any burn or other injury.The patient ended therapy and the call center advised to use manual supplies to complete therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Additional information: the device was returned and an evaluation was complete.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.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Full functional testing, electrical safety testing, calibration and simulated therapy were performed with no issues noted.The reported condition was not verified.The power supply fuse and power cord were replaced preventively.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 - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4896420
• MDR Text Key: 6535258
• Report Number: 1416980-2015-28005
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: TU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C8320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2015
• 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
• Patient Age: 34 YR
• Patient Weight: 53