BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC® IT MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML FLUSH DEVICE, 84" RED ST

    MDR report key: 16707132 · Received April 10, 2023

    Report

    Report Number
    9617594-2023-00136
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    April 5, 2023
    Report Date
    April 5, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    UDI-DI
    00840619056438
    PMA / PMN Number
    K061573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION CAN BE FOUND IN B5 AND H6.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING DEVICE WAS RETURNED FOR COMPLAINT INVESTIGATION: -ONE USED LIST #011-46106-23, TRANSPAC® IT MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML FLUSH DEVICE, 84" RED STRIPE PRESSURE TUBING AND 2 NEEDLELESS VALVES; LOT #6024115. THE REPORTED COMPLAINT OF SEPARATION WAS CONFIRMED ON THE RETURNED DEVICE. AN IMAGE WAS PROVIDED BY THE CUSTOMER SHOWING THE SEPARATION. DURING VISUAL INSPECTION, THE 25" PRESSURE TUBING WAS FOUND SEPARATED FROM THE WINGED MALE LUER. THE TUBING POCKET WAS TACKY. THE PROBABLE CAUSE OF THE TACKY PVC TUBING HAD OCCURRED DUE TO UV ADHESIVE NOT BEING FULLY CURED DURING THE ASSEMBLY PROCESS IN MANUFACTURING. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. DATE RETURNED TO MFG: 21AUG2023. UPDATED INFORMATION FROM THE MANUFACTURER CAN BE FOUND.

    Description of Event or Problem · 0

    THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THERE WAS NO ADVERSE EVENT AS ANOTHER DEVICE WAS USED IN PLACE OF THE DEFECTIVE DEVICE. THERE WAS NO NEED FOR MEDICAL INTERVENTION, NO DRUG USED WITH THIS DEVICE AND NO LEAKAGE WAS NOTED. THE CLINICIAN NOTICED THE REPORTED DEFECT WHEN HE OBSERVED THE DEVICE IN HIS HANDS. THERE WAS NO UNPROTECTED CHEMOTHERAPY EXPOSURE. THERE WAS A DELAY IN THERAPY FOR ABOUT 2 TO 3 MINUTES, CORRESPONDING TO THE AMOUNT OF THE TIME THAT WAS REQUIRED TO OBTAIN ANOTHER DEVICE FROM THE STOCK.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A TRANSPAC® IT MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML FLUSH DEVICE, 84" RED STRIPE PRESSURE TUBING AND 2 NEEDLELESS VALVES. THE CUSTOMER REPORTED THE FOLLOWING: IT WAS DISCOVERED THAT THE DEVICE TUBING WAS NOT GLUED TO THE LUER LOCK SYSTEM UPON ATTEMPTING TO CONNECT THE DEVICE TO THE PATIENT VIA AN ARTERIAL CATHETER. THE LOWER PART OF THE KIT CAME OFF ON ITS OWN AND FELL ON THE TABLE. THE KIT WAS THEN CHANGED OUT AND THE NEXT KIT WAS VERIFIED. THERE WAS NO HUMAN HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1783835 TRANSPAC® IT MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML FLUSH DEVICE, 84" RED ST TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 6024115 00840619056438

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED ARTERIAL CATHETER, MFR UNK