BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE

    MDR report key: 15691970 · Received October 28, 2022

    Report

    Report Number
    9615050-2022-00264
    Event Type
    Malfunction
    Date Received
    October 28, 2022
    Date of Event
    October 17, 2022
    Report Date
    October 17, 2022
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    00(01)(17)(10)
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    SECTIONS D4 AND H4 -PLOTS - THE CUSTOMER IDENTIFIED SEVEN POSSIBLE LOT NUMBERS (PLOTS). THE POSSIBLE LOT NUMBERS ARE 5988748 (EXPIRY DATE 06/01/2025, 06/01/2022 MFR DATE ), 5751610 (EXPIRY DATE 01/01/2025, 01/01/2022 MFR DATE ), 5230246 (EXPIRY DATE 04/01/2024, 04/01/2021 MFR DATE ), 5081986 (EXPIRY DATE 11/01/2023, 11/01/2020 MFR DATE ), 5616262 (EXPIRY DATE 11/01/2024, 10/01/2021 MFR DATE ), 5616263 (EXPIRY DATE 11/01/2024, 11/01/2021 MFR DATE ), 5696147 (EXPIRY DATE 12/01/2024, 12/1/2021 MFR DATE ).

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED 140019291 PRIMARY PLUM SET AND ONE USED MANUFACTURER UNKNOWN, DOUBLE TRIFURCATED EXTENSION SET AND ONE USED MANUFACTURER UNKNOWN, EXTENSION SET W/ STOPCOCK FOR INSPECTION. THE MATING DEVICES AND 140019291 PRIMARY PLUM SET WERE LEAK TESTED AS RECEIVED PER DESIGN SPECIFICATIONS. THERE WAS LEAKAGE OBSERVED FROM A CRACK ON THE DRY SPIKE ADAPTOR ON THE ONE USED MANUFACTURER UNKNOWN, DOUBLE TRIFURCATED EXTENSION SET AND FROM A CRACK ON THE STOPCOCK OF THE ONE USED MANUFACTURER UNKNOWN, EXTENSION SET W/ STOPCOCK FOR INSPECTION. NO LEAKAGE ON THE ONE USED 140019291 PRIMARY PLUM SET. THE NON-ICU MEDICAL MATING DEVICES WERE REMOVED AND THE RECEIVED USED 140019291 PLUM SET WAS ATTACHED TO AN ICU MEDICAL PROVIDED IV BAG, PRIMED PER PACKAGING DIRECTIONS AND A FLOW TEST WAS PERFORMED USING AN ICU PLUM PUMP. THERE WERE NO DIFFICULTIES IN PRIMING, NO CASSETTE ERRORS, NO OCCLUSION ALARMS WERE GENERATED, NO AIR IN LINE ALARMS WERE GENERATED AND NO RESTRICTIONS IN FLOW WERE OBSERVED. THE REPORTED COMPLAINT OF LEAKAGE COULD NOT BE CONFIRMED. THE LEAK WAS OBSERVED ON NON-ICU PRODUCTS. THE RECEIVED ONE USED 140019291 PRIMARY PLUM SET MET DESIGN SPECIFICATIONS. A DHR LOT # REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED. D9: DATE RETURNED TO MFR- 12/27/2022.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED STATING THERE WAS NO DELAY IN CRITICAL THERAPY AND NO MEDICAL INTERVENTION NEEDED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED AN UNSPECIFIED PRIMARY PLUM SET WHERE IT WAS REPORTED THAT CHEMOTHERAPY LEAKED. DURING AN INFUSION OF ETOPOSIDE CHEMOTHERAPY THE NURSE FOUND THAT THE PUMP WAS ALARMING OCCLUSION AND FOUND AIR IN HALF OF THE CASSETTE. THE NURSE RAN HER HAND UP THE DISTAL TUBING TO SEE IF IT WAS TWISTED OR BENT, SHE FELT FLUID ON HER FINGERS WHICH SHE THOUGHT WAS COMING FROM THE DRIP CHAMBER. THE INFUSION WAS STOPPED AND CLEANING WITH A CYTOTOXIC DECONTAMINATION KIT WAS PERFORMED. THE PUMP TUBING AND THE 4-WAY INFUSION TREE WERE DISCONNECTED FROM THE PATIENT, AND THE ETOPOSIDE BAG DISCONNECTED FROM THE TREE AND RECONNECTED TO A NEW TUBING TO ALLOW FURTHER TREATMENT. THE NURSE AND THE PATIENT WERE EXPOSED TO CYTOTOXIC PRODUCTS (DIRECTLY ON THE SKIN FOR THE NURSE, OPEN EXPOSURE FOR BOTH OF THEM), AS WELL AS TO A GREATER RISK OF MICROBIOLOGICAL CONTAMINATION BY MULTIPLE OPENINGS OF THE LINE. LEAKAGE OF ANTI-CANCER PRODUCT THROUGH THE DRIP CHAMBER WITH SPILLAGE ONTO THE TUBING, PUMP AND FLOOR. THERE WAS AIR IN THE CASSETTE, WHICH WAS RETRO-PRIMED INTO LINE B. THE NURSE THEN CHANGED THE ENTIRE LINE BY DISCONNECTING THE ANTICANCER BAG TO RECONNECT IT TO A NEW TUBING TO THE PATIENT. THE DEVICE WAS IN USE ON THE PATIENT FOR 5 HOURS. THERE WAS PATIENT INVOLVEMENT AND NURSE EXPOSURE TO CYTOTOXIC PRODUCT ON HER HANDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2795996 PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. PLOTS 00(01)(17)(10)

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female ETOPOSIDE, UNK MFR| UNSPECIFIED 4-WAY INFUSION TREE, MFR UNK| UNSPECIFIED INFUSION PUMP, UNK MFR