BEUDAMED
    FDA Adverse Event Death Summary report: N

    5FR DUAL-LUMEN UVC CATH

    MDR report key: 12050289 · Received June 23, 2021

    Report

    Report Number
    3009211636-2021-00755
    Event Type
    Death
    Date Received
    June 23, 2021
    Date of Event
    January 22, 2021
    Report Date
    June 23, 2021
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    UDI-DI
    20884527005182
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. IF ADDITIONAL INFORMATION OR THE SAMPLE IS RECEIVED, THE INVESTIGATION WILL BE REOPENED AND RESPONDED TO ACCORDINGLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PREMATURE BABY ON DAY OF LIFE (DOL) ONE DEVELOPED WORSENING DISCOLORATION OF HIS ABDOMEN AND TESTES AND ABDOMINAL DISTENTION ON (B)(6) 2021. AFTER EVALUATION BY SURGICAL SERVICES AND AN ABDOMINAL ULTRASOUND, FLUID WAS NOTED IN THE ABDOMEN. THERE WERE NO COMPLICATIONS PLACING OR SECURING THE UMBILICAL VESSEL CATHETER DUAL LUMEN (UVC) OTHER THAN IT BEING IN A LOW LYING POSITION WHICH WAS SECURED BY TAPE BRIDGE ON (B)(6) 2021. XRAY COMMENTED ON ABNORMAL PATH ON THE INITIAL READ, THOUGH IT DREW BLOOD. A REPLACEMENT OF THE UVC WAS ATTEMPTED WITH A NEW DEVICE JUST AFTER BIRTH IN THE DELIVERY ROOM. THAT SAME DAY THEY ATTEMPTED REPLACEMENT AGAIN IN THE NICU WITH A NEW DEVICE BECAUSE OF UNRESPONSIVENESS TO PRESSORS (5F DL). THEY WERE CONCERNED THAT THE PRESSORS WERE NOT WORKING. THE UVC WAS FOUND TO BE LOW LYING AGAIN AND WAS SECURED IN THE LOW LYING POSITION. A STAT ABDOMINAL ULTRASOUND WAS PERFORMED. THERE WAS CONCERN FOR THE UVC ERODING THROUGH THE VESSEL. INFUSATES WERE DOPAMINE, BLOOD, FFP, TPN/IL. CONCERN WAS RAISED BY THE SURGICAL TEAM THAT THE PATIENT MAY HAVE HAD AN INJURY DURING THE INITIAL UVC PLACEMENT AND IN THE SETTING OF COAGULOPATHY CAUSED INJURY AND EXTRAVASATION OF FLUID IN THE ABDOMEN. DUE TO WORSENING VENTILATION STATUS AND INCREASED GIRTH IN THE SETTING OF MAXIMUM MEDICAL MANAGEMENT TO CORRECT COAGULOPATHY AND PRESSORS, THE DECISION WAS MADE WITH SURGERY, THE NICU TEAM, AND THE PATIENT¿S PARENTS TO PUT IN A SURGICAL DRAIN ON DOL TWO. PERITONEAL FLUID WAS SENT FOR TRIGLYCERIDES (821) AND GLUCOSE (1165). TOTAL 95 ML/KG OF BLOODY SEROUS DRAINAGE WAS COLLECTED AND WEIGHED. THE FINDINGS WERE CONSISTENT WITH TPN INFUSION INTRA-ABDOMINALLY. THE DECISION WAS MADE TO PULL THE UVC WHICH WAS REMOVED ON DOL TWO AS THE LINE MALPOSITIONED AND WAS INFUSING MEDICATIONS AND FLUIDS INTO THE ABDOMEN. THE PATIENT HAD IMPROVED COLORATION OF THEIR ABDOMEN AND LESS DISTENTION AFTER THE DRAIN. THE PATIENT DIED AT (B)(6) BECAUSE OF SEVERE INTRACRANIAL HEMORRHAGE WHICH WAS SEEMINGLY UNRELATED. ADDITIONAL INFORMATION PROVIDED BY THE REPORTER ON JUNE 09, 2021 STATED THAT THE BABY WAS BORN VIA URGENT C-SECTION DUE TO FETAL DISTRESS AND HAD HEAD BLEEDS UPON BIRTH. THE UVC DID NOT MALFUNCTION. HOWEVER, THE TEAM KNEW THAT WHAT WAS BEING GIVEN TO THE BABY WAS NOT GOING INTO THEIR BLOOD VESSELS. THE CUSTOMER DOES NOT KNOW IF THERE WAS ANY CORRELATION BETWEEN THE PASSING OF THE BABY AND THE UVC BUT THE HEAD BLEEDS DID SEEM TO BE UNRELATED TO THE LINE. THE CAUSE OF DEATH IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    948245 5FR DUAL-LUMEN UVC CATH CATHETER, UMBILICAL ARTERY FOS COVIDIEN 8888160556 1916900048 20884527005182

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Death| O