BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHEMOCLAVE® VENTED BAG SPIKE

    MDR report key: 21048829 · Received December 31, 2024

    Report

    Report Number
    9617594-2024-01916
    Event Type
    Malfunction
    Date Received
    December 31, 2024
    Date of Event
    November 18, 2024
    Report Date
    March 3, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619023751
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE (1) VIDEO WAS PROVIDED BY THE CUSTOMER, SHOWING THE INVERSION OF THE 500ML GLUCOSE BOTTLE. RECEIVED ONE (1) LIST #CH-14, CHEMOCLAVE® VENTED BAG SPIKE; LOT #13870250. ONE (1) USED. LIST #UNKNOWN, CHI SHENG PHARMA & BIOTECH CO., LTD. GLUCOS INJECTION 5% 500 ML BOTTLE WITH PACLITAXEL AND PHYXOL INJECTION; LOT #S9058. AS RECEIVED, THE FILTER VENT SHOWS SIGNS OF BEING WETTED OUT WITH INFUSATE. THE REPORTED COMPLAINT OF A LEAK COULD BE CONFIRMED. THE SET WAS TESTED, AND A LEAK WAS OBSERVED AT THE AIR VENT. THE PROBABLE CAUSE IS FROM THE TEMPORARY LOSS OF HYDROPHOBIC PROPERTIES. PER INSTRUCTIONS, DO NOT INFUSE DILUENTS OR AIR INTO THE VIAL WHEN INVERTED, AS THIS WILL BLOCK THE FILTER AND IMPEDE VENTING. THE LOT HISTORY WAS REVIEWED, AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION; HOWEVER, THE INVESTIGATION IS NOT YET COMPLETE. ADDITIONAL CONTACT INFORMATION: (B)(6).

    Description of Event or Problem · 0

    THE EVENT INVOLVED A CHEMOCLAVE® VENTED BAG SPIKE WHERE THE CUSTOMER REPORTED A LEAK FROM THE AIRVENT DURING DRUG PHYXOL INFUSION. THERE WAS PATIENT INVOLVEMENT, NO DELAY IN CRITICAL THERAPY AND HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT. THERE WAS UNPROTECTED CHEMO EXPOSURE SINCE THE CHEMO LEAKED UNEXPECTEDLY; THE HEALTH CARE PROVIDER WORE A MASK AND MEDICAL GLOVES AND THE CHEMO DID NOT COME IN CONTACT WITH THE PATIENT OR HEALTHCARE PROVIDER. THE IMPACT ON THE PATIENT AND HEALTH CARE PROVIDER WAS THAT THEY HAD TO WAIT FOR A NEW DRUG. THE CHEMO SPILL WAS CLEANED UP PER FACILITY PROTOCOL. THERE WAS PATIENT INVOLVEMENT BUT HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088743 CHEMOCLAVE® VENTED BAG SPIKE SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 13870250 00840619023751

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown