BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSPAC IT MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, 30ML FLUSH (FOR USE WITH

    MDR report key: 11675289 · Received April 15, 2021

    Report

    Report Number
    9617594-2021-00126
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    March 26, 2021
    Report Date
    March 26, 2021
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    PMA / PMN Number
    K052828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED ONE USED LIST #42800-23, TRANSPAC¿ IT MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, 30ML FLUSH (FOR USE WITH INFUSION PUMP); LOT #UNKNOWN AND ONE USED LIST #UNKNOWN, PLUM SET; LOT #UNKNOWN. THE REPORTED COMPLAINT OF LEAKAGE WAS NOT CONFIRMED ON THE RETURNED SET. NO VISUAL ANOMALIES WERE OBSERVED. THE RETURNED SET WAS PRIMED AND PRESSURE LEAK TESTED AND NO LEAKS WERE OBSERVED. THE PRODUCT HAD PERFORMED PER THE SPECIFICATIONS. HOWEVER, NO STOPCOCK WAS RETURNED FOR EVALUATION. THE LOT HISTORY OF THE ASSUMED LOT NUMBER WAS REVIEWED AND THERE WERE NO NONCONFORMITIES WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION IN SECTION D9: THE DEVICE WAS RECEIVED FOR EVALUATION ON APRIL 1, 2021.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION. IT HAS NOT BEEN RECEIVED. THE LOT NUMBER OF THE DEVICE THAT WAS IN USE IS UNKNOWN. THE CUSTOMER IDENTIFIED TWO POSSIBLE LOT NUMBERS (PLOTS). THE POSSIBLE LOT NUMBERS ARE 4114173 (EXPIRY DATE 6/01/2022 , MFR DATE 6/01/2019), 4103118 (EXPIRY DATE 5/01/2022, MFR DATE 6/01/2019).

    Description of Event or Problem · 1

    THE EVENT OCCURRED AT 3:50 AM AND INVOLVED A TRANSPAC¿ IT MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, 30ML FLUSH (FOR USE WITH INFUSION PUMP) THAT THE CUSTOMER REPORTED AN ESTIMATED BLOOD LOSS OF 2.5 ¿ 4 CC WAS COMING OUT OF A CRACK NEAR THE STOPCOCKS. THE EVENT OCCURRED 24 HOURS AFTER IT WAS CONNECTED. THE PATIENT IS BEING TREATED FOR EXTREME PREMATURITY AND THE PATIENT STATUS WAS DESCRIBED AS CRITICAL BEFORE, DURING, AND AFTER THE EVENT. THE CUSTOMER REPORTED THE CRACK/LEAK THAT WAS NOTED NEAR THE TRANSDUCER, THE TUBING BROKE OFF FROM PORT BELOW THE PIG TAIL, AND BLOOD WAS FOUND LEAKING FROM THE OPEN PORT ONTO THE BED. HEPARIN AND NORMAL SALINE WAS CONNECTED TO THE DEVICE. THE CUSTOMER DESCRIBED THE MEDICAL INTERVENTION AS THE UMBILICAL ARTERY CATHETER HAD TO BE CLAMPED AND THE DEVICE WAS REPLACED AND THERAPY WAS RESUMED. THE BABY WAS TREATED WITH ANTIBIOTICS PROPHYLACTICALLY DUE TO BREAK IN THE CENTRAL LINE. THERE WERE NO HOLES, CUTS, OR TEARS NOTED. THE ISSUE DID NOT PROLONG THE PATIENT'S HOSPITAL STAY AND THE PATIENT HAS NOT BEEN DISCHARGED. THERE WAS PATIENT INVOLVEMENT, HOWEVER, NO REPORTED DELAY IN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566923 TRANSPAC IT MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, 30ML FLUSH (FOR USE WITH TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 3 DA HEPARIN, MFR UNK| NORMAL SALINE, MFR UNK