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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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BAXTER HEALTHCARE - SINGAPORE HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number R5C4479
Device Problems Tube; Material Perforation
Event Date 11/25/2018
Event Type  Malfunction  
Manufacturer Narrative

The device was received from evaluation. A visual inspection was performed with no issues noted. An underwater pressure test was performed with no issues noted. The reported issue was not verified. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of the three suspected lots. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported there was a hole on the outlet tubing at the connection between the tubing and the outlet cap of a homechoice automated pd therapy cassette. The hole in the tubing was observed prior to patient therapy. There was no patient injury or medical intervention associated with this event. No additional information is available.

 
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Brand NameHOMECHOICE AUTOMATED PD SET WITH CASSETTE
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 Key8204258
Report Number1416980-2018-08074
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 12/28/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberR5C4479
Device LOT NumberASKU
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/10/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/03/2018
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

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