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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; Fluid Leak
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that the tube of a homechoice automated pd set with cassette leaked. This event occurred during setup with patient involvement. The care giver stated that they had removed the cassette from the over pouch and noticed one of the lines coming from the cassette was bent. The care giver set up the disposable and during priming, while the patient was not connected, the bent tubing began to leak. Priming was discontinued, the disposable was removed and another cassette was used. There was no patient injury or medical intervention associated with this event. No additional information is available.

 
Manufacturer Narrative

Additional information provided for. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not returned; therefore, a device analysis could not be completed. 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 Key7203176
Report Number1416980-2018-00225
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 02/02/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberL5C4531
Device LOT NumberH17K07038
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 Received01/27/2018
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: 01/18/2018 Patient Sequence Number: 1
Treatment
HOMECHOICE
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