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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - SINGAPORE HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C4474
Device Problem Temperature Problem
Event Date 02/08/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that a homechoice cycler did not heat the peritoneal dialysis solution. The device displayed that the solution was warming. Therapy could not be performed. There was no patient injury or medical intervention associated with this event. No additional information is available.

 
Manufacturer Narrative

The device was returned and evaluated for the reported issue of solution not heating. The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue. The event history log only noted check heater line alarms for the day of the reported issue. The device was visually inspected and nothing was found related to the described problem. The machine also passed all functional testing and noted that there were no temperature issues during the testing. A simulated therapy was performed and the machine was found to be working correctly. The reported event was not verified. Some unrelated issues were found during visual inspection and the necessary parts were installed. Should additional relevant information become available, a supplemental report will be submitted.

 
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Brand NameHOMECHOICE
Type of DeviceSYSTEM, 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 Key7313369
Report Number1416980-2018-01131
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 04/06/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/05/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number5C4474
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/06/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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