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

Catalog Number R5C8320

Device Problem Noise, Audible (3273)

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

Event Date 04/27/2014

Event Type  malfunction  

Event Description

It was reported that the home choice (hc) made an electric, sizzling like noise when the patient attempted to turn on the 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).Although the device was unable to power on, the reported issue of an electrical sizzling noise was not able to be verified during the evaluation of the homechoice (hc).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).(b)(6).The device was returned to baxter and the evaluation is complete.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 event log was unable to be downloaded from the device as the device was unable to be powered on.A visual inspection was performed and found no issues.The power supply of the device was replaced.The device was then able to pass functional testing, electrical safety testing, calibration, and a simulated therapy test with no additional issues noted.The reported issue was not duplicated during the evaluation.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; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3898547
• MDR Text Key: 4672163
• Report Number: 1416980-2014-20418
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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,Followup
• Report Date: 04/28/2014

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: Lay User/Patient
• Device Catalogue Number: R5C8320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 06/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2014
• 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