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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE LOW RECIRCULATION VOLUME APD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number N5C8305C
Device Problems Tube; Fluid Leak; Material Perforation
Event Date 11/27/2018
Event Type  Malfunction  
Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that two (2) homechoice low recirculation volume apd cassettes had holes in the patient line which resulted in leaks. The leaking was discovered while the patient was connected for treatment. There was no patient injury or medical intervention associated with this event. No additional information is available.

 
Manufacturer Narrative

Describe event or problem: there was no patient injury, however, the patient received prophylactic treatment due to the event. (previously reported as no medical intervention associated with this event). Should additional relevant information become available, a supplemental report will be submitted.

 
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Brand NameHOMECHOICE LOW RECIRCULATION VOLUME APD 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 Key8191504
Report Number1416980-2018-07991
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/26/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/21/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberN5C8305C
Device LOT NumberH18H16033
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2019
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: 12/21/2018 Patient Sequence Number: 1
Treatment
UNSPECIFIED PD SOLUTION
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