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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 Problems Tube; Fluid Leak; Material Perforation
Event Date 08/30/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that an amia automated peritoneal dialysis set with cassette leaked fluid from a hole in the tubing. The caregiver stated that the solution leaked out and onto the floor. The cause of the perforated tubing was unknown. The patient was brought to the hospital and was administered prophylactic antibiotics. No further medical intervention was reported for this event. Patient outcome was not reported. No additional information is available.

 
Manufacturer Narrative

Upon review, it was noted there was no report of hospital admission and the antibiotic treatment was for precautionary measures, therefore, the amia apd set with cassette is no longer considered suspect in this event. Should additional relevant information become available, a supplemental report will be submitted.

 
Manufacturer Narrative

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 received for evaluation; 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 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 Key7902586
Report Number1416980-2018-06118
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 10/24/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue Number5C5479
Device LOT NumberH18E17102
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 Received10/12/2018
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: 09/24/2018 Patient Sequence Number: 1
Treatment
AMIA AUTOMATED PD SYSTEM
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