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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 Tube; Bent; Hole In Material
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The event/therapy occurred on an unspecified date in 2017. 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 there was a hole near the top of the patient line tubing of a homechoice cassette, and the line was bent. The reported problem was observed during a demonstration of therapy set up; the patient was in training. There was no patient injury or medical intervention associated with this event. No additional information is available.

 
Manufacturer Narrative

The device was returned and an evaluation is complete. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Visual inspection was performed with no issues noted. Leak testing, clear passage test, clamp function test and device-device interaction testing was performed with no issues noted. The reported condition (hole in the tubing or near the top of the patient line and bent/kinked tubing) was not verified. 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 Key6394995
Report Number1416980-2017-02052
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberL5C4531
Device LOT NumberH16K01016
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/23/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/12/2017
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

Patient TREATMENT DATA
Date Received: 03/10/2017 Patient Sequence Number: 1
Treatment
HOMECHOICE
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