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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION AMIA AUTOMATED PD CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
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BAXTER HEALTHCARE CORPORATION AMIA AUTOMATED PD CYCLER SET; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C5479
Device Problems Crack (1135); Protective Measures Problem (3015)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/09/2020
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 device experienced a low priority (max air exceeded) alarm.The patient was connected at the time of the alarm.This occurred during patient infusion of peritoneal dialysis therapy.It was further reported the patient line cracked due to "too much pressure"; the tube split and sucked in air which led to the alarm.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Correction made to d2b: classification code: fkx (previously submitted as kdj).H10: the device was not returned.And the lot number is unknown.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 Name
AMIA AUTOMATED PD CYCLER SET
Type of Device
SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11117592
MDR Text Key225108762
Report Number1416980-2020-08306
Device Sequence Number1
Product Code FKX
Combination Product (y/n)Y
PMA/PMN Number
K151525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number5C5479
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received02/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
AMIA AUTOMATED PD SYSTEM; AMIA AUTOMATED PD SYSTEM
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