BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUNZON CHEMOCLAVE PARA BOLSA/BOTELLA CON FILTRO DE VENTEO

    MDR report key: 11296579 · Received February 8, 2021

    Report

    Report Number
    9617594-2021-00036
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Date of Event
    February 1, 2021
    Report Date
    February 1, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    ONB
    PMA / PMN Number
    K173477
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - ADDITIONAL INFORMATION CAN BE FOUND IN B5 AND D10.

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLES WERE RETURNED FOR INVESTIGATION, HOWEVER, A PHOTO WAS PROVIDED AND EVALUATED. THE PHOTO SHOWS ONE CHEMOCLAVE CONNECTED TO A SPIROS. LEAKAGE CAN BE SEEN FROM THE CHEMOCLAVE/SPIKE BOND. NO OTHER DAMAGE OR ANOMALIES CAN BE SEEN IN THE IMAGE. THE DEVICE HISTORY RECORDS (DHRS) WERE REVIEWED FOR POSSIBLE LOT NUMBERS 4953206, 4977193 OR 4866361 WERE REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE REPORTED COMPLAINT OF LEAKAGE CAN BE CONFIRMED BASED ON THE PHOTO PROVIDED HOWEVER, WITHOUT THE RETURN OF THE SAMPLE A PROBABLE CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE CUSTOMER STATED THAT THE LEAKAGE OCCURRED IN THE PHARMACY SERVICE DURING THE PREPARATION. THERE WAS NO UNPROTECTED EXPOSURE OF CHEMOTHERAPY.

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION. WITHOUT THE RETURNED DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER IDENTIFIED THREE POSSIBLE LOT NUMBERS: 4953206 (EXPIRY DATE 08/01/2025, MFR DATE 08/01/2020), 4977193 (EXPIRY DATE 08/01/2025, MFR DATE 08/01/2020) AND 4866361 (EXPIRY DATE 05/01/2025, MFR DATE 05/01/2020).

    Description of Event or Problem · 1

    THE EVENT INVOLVED A CHEMOCLAVE THAT PRESENTED LEAKAGE OF DILUTED ETOPOSIDE THROUGH THE CONNECTION OF THE CLAVE WITH THE SPIKE DURING INFUSION. THE REPORTER ADDED THAT FROM PREPARATION TO INFUSION, 2.5 HOURS HAD PASSED. THERE WAS PATIENT INVOLVEMENT AND A DELAY IN THERAPY, HOWEVER NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190899 PUNZON CHEMOCLAVE PARA BOLSA/BOTELLA CON FILTRO DE VENTEO CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM ONB ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 ETOPOSIDE, UNK MFR