BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 10454579 · Received August 26, 2020

    Report

    Report Number
    2016493-2020-03154
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Report Date
    August 7, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: OMIT QUALITY ENGINEER IN E3 (OTHER OCCUPATION)

    Description of Event or Problem · 0

    IT WAS REPORTED FROM NEONATAL INTENSIVE CARE UNIT THAT BLOOD WAS BACKING UP THROUGH UTAH MEDICAL PRODUCTS INC.'S NEONATAL/PEDIATRIC DELTRAN® PLUS (PRODUCT ABC-328NP) KIT AND INTO THE ADMINISTRATION SET 2420-0007. THERE WAS NO REPORTED LEAKS. IT WAS ALSO REPORTED THAT SOMETIMES AFTER BLOOD DRAWS AND SOMETIMES NOT, THEY NOTED BLOOD BACKING UP PAST THE NEONATAL/PEDIATRIC DELTRAN® PLUS (PRODUCT ABC-328NP) SET. THE HOSPITAL WAS ABLE TO INFUSE AND DRAW BLOOD OTHERWISE EFFECTIVELY. THE HOSPITAL HAD RECENTLY CHANGED OVER TO USING THE NEONATAL/PEDIATRIC DELTRAN® PLUS (PRODUCT ABC-328NP) KITS. THE KIT WAS RETURNED FROM THE FACILITY AND THE COMPANY HAS EVALUATED IT AND HAS NOT FOUND AN ISSUE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM NEONATAL INTENSIVE CARE UNIT THAT BLOOD WAS BACKING UP THROUGH (B)(6) MEDICAL PRODUCTS INC.'S NEONATAL/PEDIATRIC DELTRAN® PLUS (PRODUCT ABC-328NP) KIT AND INTO THE ADMINISTRATION SET 2420-0007. THERE WAS NO REPORTED LEAKS. IT WAS ALSO REPORTED THAT SOMETIMES AFTER BLOOD DRAWS AND SOMETIMES NOT, THEY NOTED BLOOD BACKING UP PAST THE NEONATAL/PEDIATRIC DELTRAN® PLUS (PRODUCT ABC-328NP) SET. THE HOSPITAL WAS ABLE TO INFUSE AND DRAW BLOOD OTHERWISE EFFECTIVELY. THE HOSPITAL HAD RECENTLY CHANGED OVER TO USING THE NEONATAL/PEDIATRIC DELTRAN® PLUS (PRODUCT ABC-328NP) KITS. THE KIT WAS RETURNED FROM THE FACILITY AND THE COMPANY HAS EVALUATED IT AND HAS NOT FOUND AN ISSUE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919202 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 2420-0007,8015, TD UNK