BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 8500210 · Received April 10, 2019

    Report

    Report Number
    9616066-2019-01000
    Event Type
    Malfunction
    Date Received
    April 10, 2019
    Report Date
    March 18, 2019
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    07613203019088
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER¿S REPORT OF TUBING DISCONNECTED AT PUMPING SEGMENT WAS CONFIRMED. VISUAL INSPECTION OF THE SET NOTED THAT THE SILICONE SEGMENT WAS COMPLETELY SEPARATED FROM THE UPPER FITMENT. FURTHER VISUAL INSPECTION OF SEPARATED SILICONE SEGMENT END NOTED NO O-RING INDENTATIONS ON THE SILICONE SEGMENT. EXAMINATION UNDER MAGNIFICATION NOTED NO CRUSH MARK TO THE UPPER OR LOWER FITMENT. NO OTHER ANOMALIES WERE NOTED. FUNCTIONAL TESTING WAS DEEMED UNNECESSARY DUE TO A SEPARATION IN THE SILICONE TUBING. DIMENSIONAL ANALYSIS OF THE SILICONE SEGMENT WERE MEASURED TO BE WITHIN SPECIFICATION. THE ROOT CAUSE OF THE PRIMARY SET SILICONE SEGMENT SEPARATION WAS DUE TO THE SET'S RETAINER RING NOT BEING ASSEMBLED ONTO THE SET DURING MANUFACTURING ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "TPN WAS PRIMED AND READY TO HANG, THIS NURSE BEGAN TO PLACE IT INTO ALARIS PUMP WHEN TUBING DISCONNECTED AT SITE OF "PUMP SECTION" WHERE IT CONNECTS TO BLUE PLASTIC PIECE. TO BE SPECIFIC, THE TUBING HAD NOT EVEN BEEN PUSHED INTO PLACE WITHIN THE PUMP WHEN IT DISCONNECTED ON ITS OWN. THIS NURSE IMMEDIATELY ROLLER CLAMPED ABOVE AND BELOW BREAKAGE AND HELD ON TO BOTH PIECES TO INSURE STERILITY WAS MAINTAINED. RESOURCE NURSE WAS CALLED TO ASSIST, SHE BROUGHT NEW STERILE TUBING AND RE-SPIKED BAG WHILE THIS NURSE CONTINUED TO ENSURE ENDS OF OLD TUBING DIDN'T COME IN CONTACT WITH ANY SURFACES DURING THE TRANSFER. NO HARM WAS CAUSED TO PATIENT." AN INCOMPLETE DATE OF EVENT OF (B)(6)-2019 WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED. PATIENT AGE AND DATE OF BIRTH WAS REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "TPN WAS PRIMED AND READY TO HANG, THIS NURSE BEGAN TO PLACE IT INTO ALARIS PUMP WHEN TUBING DISCONNECTED AT SITE OF "PUMP SECTION" WHERE IT CONNECTS TO BLUE PLASTIC PIECE. TO BE SPECIFIC, THE TUBING HAD NOT EVEN BEEN PUSHED INTO PLACE WITHIN THE PUMP WHEN IT DISCONNECTED ON ITS OWN. THIS NURSE IMMEDIATELY ROLLER CLAMPED ABOVE AND BELOW BREAKAGE AND HELD ON TO BOTH PIECES TO INSURE STERILITY WAS MAINTAINED. RESOURCE NURSE WAS CALLED TO ASSIST, SHE BROUGHT NEW STERILE TUBING AND RE-SPIKED BAG WHILE THIS NURSE CONTINUED TO ENSURE ENDS OF OLD TUBING DIDN'T COME IN CONTACT WITH ANY SURFACES DURING THE TRANSFER. NO HARM WAS CAUSED TO PATIENT." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294941 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10933805 07613203019088

    Patients

    Seq Age Sex Outcome Treatment
    1 (2)CUROS ALCOHOL DISINFECTANT CAPS| NON-BD EXTENSION SET, THERAPY DATE UNK| NON-BD EXTENSION SET, THERAPY DATE UNK