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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number L5C4531
Device Problems Connector; Tube; Bent; Tear, Rip or Hole in Device Packaging
Event Date 02/03/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). The device has been received and the evaluation is in progress. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that the patient line connector of the homechoice cassette was bent and there was a hole in the tubing. This was observed prior to use and there was no patient involvement. No additional information is available.

 
Manufacturer Narrative

The device was received for evaluation. Visual inspection identified patient line position relative to organizer out of tolerance with bent tubing (walls not touching). Functional testing performed included leak testing, clear passage test, clamp function test, and device-device interaction testing, and no issues were noted. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The reported condition was verified. The cause of the condition was determined to be a manufacturing issue. A nonconformance has been opened to address this issue. Should additional relevant information become available, a supplemental report will be submitted.

 
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Brand NameHOMECHOICE AUTOMATED PD SET WITH CASSETTE
Type of DeviceSYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE - MOUNTAIN HOME
mountain home AR
Manufacturer (Section G)
BAXTER HEALTHCARE - MOUNTAIN HOME
1900 n highway 201
mountain home AR 72653
Manufacturer Contact
25212 w. illinois route 120
round lake , IL 60073
2242702068
MDR Report Key6362397
Report Number1416980-2017-01658
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/31/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberL5C4531
Device LOT NumberH16A25064
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/13/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2017
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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