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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 Material Puncture/Hole (1504)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/16/2023
Event Type  malfunction  
Manufacturer Narrative
The device was received and is currently awaiting evaluation.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the patient line of six (6) amia automated pd cycler sets were ¿pierced¿.The damaged sets were discovered during set up of the device for 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: eight (8) actual samples were received for evaluation.A visual inspection with the naked eye was performed and a slight indentation on the patient line tubing was observed on all samples.Slight tubing indentations are cosmetic in nature and should have no impact on the functionality of the device.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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
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 Key16541747
MDR Text Key311485788
Report Number1416980-2023-01077
Device Sequence Number1
Product Code FKX
UDI-Device Identifier00085412153186
UDI-Public(01)00085412153186
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 04/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number5C5479
Device Lot NumberH22K29050
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/07/2023
Initial Date Manufacturer Received 02/16/2023
Initial Date FDA Received03/14/2023
Supplement Dates Manufacturer Received04/10/2023
Supplement Dates FDA Received04/13/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
AMIA AUTOMATED PD SYSTEM; UNSPECIFIED SOLUTION
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