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

Catalog Number R5C8320

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2014

Event Type  malfunction  

Event Description

It was reported that an unspecified failure occurred with the home choice (hc).The technical service representative (tsr) arranged the return of the device.No patient injury or medical intervention was indicated as a result of this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was reported to be available but has not yet been received.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The homechoice (hc) was returned and evaluated.The event history log review indicated several alarms, but as the reported alarm was unknown, the problem could not be confirmed though the logs.Visual and functional testing of the device could not confirm the reported problem.A service history review showed no failures/problems that were the same as, or similar to, the current difficulty.In addition, there was no indication that the parts replaced during servicing caused or contributed to the reported difficulty.A review of the device history records revealed no issues that could have caused or contributed to the reported difficulty.The reported problem was unable to be confirmed during sample analysis.Upon completion of the evaluation or upon receipt of additional information, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Full functional testing, electrical safety testing , calibration and simulated therapy was performed with no additional defects and malfunctions found with the device.Should additional relevant information become available, a follow-up 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3787598
• MDR Text Key: 4387529
• Report Number: 1416980-2014-14261
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup,Followup
• Report Date: 04/08/2014

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: Other
• Device Catalogue Number: R5C8320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2014
• Initial Date FDA Received: 05/02/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/06/2014; 07/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2003
• 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