BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VA

    MDR report key: 15940820 · Received December 8, 2022

    Report

    Report Number
    9617594-2022-00319
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    October 17, 2022
    Report Date
    November 10, 2022
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    D9 - DATE RETURNED TO MFG IS 8/9/2023. THE SINGLE USED 011-AM6118 EXT SET W/6-PORT NANOCLAVE MANIFOLD WAS PRESSURE LEAK TESTED AND LEAKAGE WAS OBSERVED AT THE BONDED CONNECTION BETWEEN THE MALE LUER AT THE DISTAL END OF THE 6-PORT NANOCLAVE MANIFOLD AND THE FEMALE LUER ON THE EXTENSION SET. THE FEMALE LUER WAS OBSERVED TO HAVE AN INCOMPLETE CONNECTION TO THE MALE LUER OF THE MANIFOLD RESULTING IN LEAKAGE. THE PROBABLE CAUSE OF THE LEAKAGE IS AN INCOMPLETE BOND CONNECTION DURING MANUAL ASSEMBLY. A DEVICE HISTORY REPORT (DHR) LOT # REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VALVE, NANOCLAVE® (RED RINGS), ROTATING LUER WHERE IT WAS REPORTED THAT THE EQUIPMENT WAS IN PLACE AT THE LEVEL OF THE PROXIMAL LINE TO THE PATIENT'S CENTRAL LINE. NORADRENALINE WAS ADMINISTERED BECAUSE THE PATIENT WAS HYPOTENSIVE AND AFTER A FEW MINUTES THE BLOOD PRESSURE WAS STILL NOT SATISFACTORY DESPITE AN INCREASE IN THE DOSE OF NORADRENALINE. THE CUSTOMER NOTICED A PRODUCT LEAK ON THE SHEET. LEAK AT THE LEVEL OF THE LLM CONNECTION OF THE DEVICE. CLINICAL CONSEQUENCE: HYPOTENSION WHICH AGGRAVATES THE PATIENT'S CLINICAL CONDITION. THIS INCIDENT TOOK PLACE IN SURGICAL INTENSIVE CARE. THE PATIENT'S CONDITION SHOWED NO IMPROVEMENT OF THE HYPOTENSION FOR APPROXIMATIVELY THIRTY MINUTES, THE TIME IT TOOK TO NOTICE THE LEAK. AFTERWARDS, THE HYPOTENSION WAS RESOLVED ALTHOUGH IT PERSISTED. THERE WAS A DELAY IN THERAPY OF THIRTY MINUTES, THE TIME IT TOOK TO NOTICE THE ISSUE. THERE WAS NO NEED FOR MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT BUT NO REPORT OF HUMAN HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2136619 PROXIMALE - 28 CM (11") SMALLBORE EXT SET W/6-PORT NANOCLAVE® MANIFOLD, CHECK VA STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NORADRENALINE, MFR UNK.