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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME AMIA AUTOMATED PD CYCLER SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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BAXTER HEALTHCARE - MOUNTAIN HOME AMIA AUTOMATED PD CYCLER SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C5479
Device Problem Material Perforation
Event Type  Malfunction  
Manufacturer Narrative

Event date was sometime in (b)(6) 2018. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that a hole was found in an amia cassette. The location was not reported. The reporter stated that the device displayed ¿cassette failure¿ when using the cassette. The reporter stated that they completed therapy by using cassette with a different lot number. There was no patient injury or medical intervention associated with this event. No additional information is available.

 
Manufacturer Narrative

The actual device was not available; however, a companion sample was received for evaluation. A visual inspection was performed with naked eye with no issues noted. Functional testing including leak testing, clear passage testing and clamp function testing were performed with no issues 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 problem was not verified. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

 
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Brand NameAMIA AUTOMATED PD CYCLER SET
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 Key7668517
Report Number1416980-2018-04162
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 08/09/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/07/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue Number5C5479
Device LOT NumberH18A28082
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 Received08/02/2018
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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