BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN

    MDR report key: 18279737 · Received December 6, 2023

    Report

    Report Number
    9615050-2023-00754
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 1, 2023
    Report Date
    November 13, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    UDI-DI
    10887787008804
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION AS THE CUSTOMER HAS DISCARDED IT. WITHOUT THE RETURN OF THE DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    GCM RECEIVED AN EMAIL FROM (B)(4) A PRODUCT MANAGER FROM A-STRONG CO. LTD ON (B)(6)2023. THE REPORT INITIALLY CAME FROM A STAFF FROM (B)(6) HOSPITAL WITH REGARD TO A PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN WITH LIST NUMBER: 142730490 WITH LOT NUMBER: 13547923. THE REPORTER STATED, ¿2 SETS HAD N185 ALARM, TRIED 2 PUMPS AND HAVING SAME ISSUE..¿ THE EVENT OCCURRED DURING INFUSION OF UNKNOWN CHEMO DRUG. THERE WAS NO OBVIOUS DEFECTS NOTED ON THE TUBING SET SUCH AS CRACKS OR BREAKS WITH NO ANY HOLE, CUT, TEARS OR ANY OTHER DEFECTS NOTED. THE TUBING WAS REPLACED AND THERAPY WAS RESUMED. THE PRODUCTS WERE STORED IN THE AIR-CONDITIONED ROOM IN THE HOSPITAL AND WAS NOT EXPOSED IN EXTREME TEMPERATURE CONDITION. THERE WAS A N185 ALARM INVOLVING A PLUM A+ MATING DEVICE. THE CUSTOMER DOES NOT REQUIRE AN ANALYSIS REPORT. THE SAMPLE IS NOT AVAILABLE FOR RETURN SINCE ALREADY DISCARDED DUE TO CHEMO DRUG BIOHAZARD. SAMPLE PICTURE IS NOT AVAILABLE. THERE WAS NO FURTHER INFORMATION AVAILABLE. THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM. (B)(4). (B)(6) 2023 UPDATE: GCM RECEIVED AN EMAIL FROM PEGGY HSU, A PRODUCT MANAGER FROM A-STRONG CO. LTD ON (B)(6) 2023 STATING THAT THERE WAS NO UNPROTECTED CHEMO EXPOSURE TO THE PATIENT AND HEALTHCARE PROVIDER. (B)(4). (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1365966 PLUM 150 ML BURETTE SET, CLAVE INJECTION SITE, 2 CLAVE Y-SITES, SL, 114IN SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. 13547923 10887787008804

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown