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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 Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/23/2023
Event Type  malfunction  
Event Description
It was reported that a patient experienced air in the patient line of two (2) amia automated pd cycler sets.During the initial drain of peritoneal dialysis (pd) therapy, multiple air bubbles were observed in the tubing.Renal therapy services (rts) assisted the patient with starting therapy over.After completing the cassette test and priming, air bubbles were again observed within the patient line and solution lines.The patient was connected for therapy at the time of this event.Rts advised to end the therapy session and continuous ambulatory peritoneal dialysis was discussed.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
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
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 Key18544025
MDR Text Key333455307
Report Number1416980-2023-07094
Device Sequence Number1
Product Code FKX
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 02/16/2024
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 NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/24/2023
Initial Date FDA Received01/19/2024
Supplement Dates Manufacturer Received02/14/2024
Supplement Dates FDA Received02/16/2024
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
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