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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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BAXTER HEALTHCARE CORPORATION SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number ASKU
Device Problems Cassette; Fluid Leak; Material Perforation
Event Date 11/14/2018
Event Type  Malfunction  
Manufacturer Narrative

The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. However, a leak was identified on the homechoice cassette due to a pinhole. The cause of the pinhole was not determined. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that a homechoice cassette leaked. This was found during set-up of the device. The home patient (hp) was not connected during the time of the event. The hp stated that upon starting the therapy, they noticed a leak from the machine. Upon opening the door, they noticed a busting pinhole leak from the cassette. The cassette and the supplies were replaced. Renal therapy services discussed the use of continuous ambulatory peritoneal dialysis. There was no patient injury or medical intervention associated with this event. No additional information is available.

 
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Brand NameNI
Type of DeviceSYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
ni
Manufacturer (Section G)
BAXTER HEALTHCARE CORPORATION
ni
ni
ni
Manufacturer Contact
25212 w. illinois route 120
round lake , IL 60073
2242702068
MDR Report Key8146743
Report Number1416980-2018-07714
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 12/10/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/10/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberASKU
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2018
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: 12/10/2018 Patient Sequence Number: 1
Treatment
HOMECHOICE PRO
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