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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 Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/18/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that white connector on the patient line of an amia automated pd set with cassette was cracked.This occurred before use of peritoneal dialysis therapy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H10: 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 discarded; 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 Key12006064
MDR Text Key260800657
Report Number1416980-2021-03672
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00085412153186
UDI-Public(01)00085412153186
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 07/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date10/02/2023
Device Catalogue Number5C5479
Device Lot NumberH21D02045
Was Device Available for Evaluation? No
Date Manufacturer Received06/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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