BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK

    MDR report key: 20767061 · Received November 24, 2024

    Report

    Report Number
    9615050-2024-00855
    Event Type
    Malfunction
    Date Received
    November 24, 2024
    Date of Event
    January 1, 2024
    Report Date
    November 24, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FPA
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 - DATE OF EVENT - THE DATE OF EVENT IS UNKNOWN, AND 01 JAN 2024 HAS BEEN USED AS A PLACEHOLDER. D4 AND H4 THE LOT#, EXPIRATION DATE, AND MANUFACTURE DATE ARE UNKNOWN. G4 - THE CATALOG NUMBER IS NOT KNOWN, K141789 HAS BEEN USED AS A PLACE HOLDER. INVESTIGATION SUMMARY: NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. THE COMPLAINT ABNORMAL DRIPPING RATE AND SUNKEN SECONDARY PORT COULD NOT BE CONFIRMED BY INVESTIGATION. WITHOUT THE RETURN OF THE USED SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED. A LOT HISTORY REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.

    Description of Event or Problem · 0

    A COMPLAINT WAS RECEIVED WITH REGARDS TO A SECONDARY PORT OF AN UNSPECIFIED PRIMARY IV TUBING SET . THE REPORTER STATED THAT THEY RECEIVED A REPORT ABOUT FAILURE OF SECONDARY VALVE OF PRIMARY IV TUBING KIT ON (B)(6) 2024. THEY HAVE TWO POSSIBLE CHOICES FOR THIS ITEM REPORTED: PRIMARY SET 3-CLAVE PIGGY BACK W/ BACKCHECK VALVE / 12664-28 AND/OR PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK, 14687-28. THE REPORTER ALSO ADDED, "HOOKED CARBOPLATIN ONTO SECONDARY PORT OF PRIMARY IV TUBING SET. PUMP ALMOST IMMEDIATELY GAVE A PROXIMAL OCCLUSION BELL, LOOKED AT SECONDARY LINE AND NO OCCLUSION FOUND, PRESSED START AGAIN AND NOTICED LINE WASN'T DRIPPING AT A NORMAL RATE BUT WAS SINGLE DRIPS INCONSISTENTLY, AGAIN PUMP ALARMED, THIS 'RN REMOVED LINE FROM PRIMARY CASSETTE AND NOTICED THE STOPPER IN THE SECONDARY PORT WAS STUCK IN.  VERY LITTLE CARBO WAS IN THE LINE/WASTED, PRIMARY LINE WAS DISCONNECTED FROM PATIENT AND REPLACED". THE EVENT DATE WAS UNKNOWN. THEY NO LONGER HAVE THE SAMPLE AS IT WAS DISPOSED. THUS, THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT, UNKNOWN HUMAN HARM AND UNKNOWN DELAY IN THERAPY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1799930 UNSPECIFIED PRIMARY PLUM SET CLAVE PORT, CLAVE Y-SITE, SECURE LOCK SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL COSTA RICA LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown