BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    43 CM (17") BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), PLUG ADAPTER

    MDR report key: 17911791 · Received October 11, 2023

    Report

    Report Number
    9617594-2023-00819
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 11, 2023
    Report Date
    September 20, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619070076
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLES WERE RETURNED FOR INVESTIGATION. HOWEVER, A SERIES OF PHOTOGRAPHS WERE RETURNED SHOWING THE DRIP CHAMBER SPIKE OF AN UNIDENTIFIED INFUSION SET INSERTED INTO THE SPIKE ADAPTER OF A 061-CH3139 ADAPTER SET AND LEAKAGE CONFIRMED AT THE INTERFACE OF THE TWO COMPONENTS. WITHOUT RETURN OF THE AFFECTED SAMPLES A COMPREHENSIVE INVESTIGATION CANNOT BE CONDUCTED AND A PROBABLE CAUSE CANNOT BE DETERMINED. THE LOT HISTORY REVIEW FOR LOT 13583565 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AS THE CUSTOMER HAS DISCARDED IT. THE CUSTOMER DID PROVIDE A PHOTO, BUT EVALUATION IS PENDING.

    Description of Event or Problem · 0

    THE INCIDENT INVOLVED A 43 CM (17") BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), PLUG ADAPTER. THE REPORTER MENTIONED THAT THEY HAVE BEEN HAVING SOME ISSUE WITH THE TWO TAIL SPIKES (BIFUSE) LINES AND FLUID LEAKS AND IT OCCURS AT THE BIFUSE LINE OR THE GIVING SET SPIKE UNION. THEY FOUND OUT THAT IF THE GIVING SET IS NOT PUSHED ALL THE WAY IN, FLUID LEAKING OCCURRED. THE CUSTOMER ALSO STATED THAT THEY MADE IT A PART OF THEIR TIMEOUT PROCESS TO ENSURE THE GIVING SET IS INSERTED FULLY AND NO SIGNS OF FLUID WEEPING/LEAKING BEFORE COMMENCING ANTI-CANCER MEDS (OR ANY TREATMENTS). INITIALLY THEY THOUGHT THE ISSUE WAS HUMAN ERROR, NOT HAVING INSERTED THE GIVING SET SPIKE FAR ENOUGH INTO THE BIFUSE LINE. IT DOESN¿T APPEAR TO BE HUMAN ERROR HOWEVER AS THE ISSUE CONTINUED TO HAPPEN AND MORE IMPORTANTLY, AT RANDOM TIMES DURING THE TREATMENT/INFUSION TIME ¿ IT MAY BE FINE FOR THE SALINE PRIME AND DURING PREMEDS BUT A WEEP/LEAK OF FLUID WILL BE NOTED LATER. THE EVENT OCCURRED DURING USE IN PATIENT FOR CISPLATIN WHERE THE PATIENT COULD HAVE BEEN IN THE CHAIR FOR SEVERAL HOURS BEFORE THE WEEP WAS NOTICED AND WITH SMALL DROPLETS OF MOISTURE WAS NOTED ON THE FLOOR FROM THIS INCIDENT. ON ALL OCCASIONS NO OBVIOUS SIGNS OF DAMAGE/DEFECT. THERE WAS NO UNPROTECTED CHEMOTHERAPY EXPOSURE TO THE PATIENT, HEALTH CARE WORKER OR OTHER PERSONNEL ONLY SMALL WEEP DETECTED AT END OF INFUSION. THE SET WAS NOT REPLACED SINCE THE WEEP WAS DETECTED AT END OF INFUSION. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179478 43 CM (17") BIFUSE ADD-ON SET W/2 BAG SPIKES, 2 CLAMPS (RED, BLUE), PLUG ADAPTER STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13583565 00840619070076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown CISPLATIN, MFR UNK| VOLUMAT LINE VL ST02-ND, FRESENIUS KABI