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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 Connector; Misconnection
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that the luer connector of a homechoice automated pd set with cassette could not connect to the solution bag completely. The cassette and solution bag were both changed to resolve the issue. This event occurred before use with patient involvement. 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 Key6597880
Report Number1416980-2017-04575
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 05/30/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/30/2017
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/08/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 05/30/2017 Patient Sequence Number: 1
Treatment
EXTRANEAL 2L SINGLE BAG
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