BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW CVC SET: 2-LUMEN 4 FR X 8 CM

    MDR report key: 7515528 · Received May 15, 2018

    Report

    Report Number
    3006425876-2018-00294
    Event Type
    Injury
    Date Received
    May 15, 2018
    Date of Event
    April 12, 2018
    Report Date
    May 2, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: IN THE RESUSCITATION ROOM, CONCERNING A PREMATURE NEW-BORN BABY WHO HAD A SURGERY ON (B)(6) 2018 FOR ILEO-COLIC RESECTION WITH INSERTION OF A STOMA. A PEDIATRIC CVC IS INSERTED IN THE SUPRACLAVICULAR WAY DURING THE INTERVENTION. THE NEWBORN IS THEN SENT TO INTENSIVE CARE. ON THE (B)(6) 2018, DISCOVERY OF A "PERFUSOTHORAX" (MIGRATION OF THE CATHETER) WITH CARDIORESPIRATORY INSUFFICIENCY. WITH ALSO A RIGHT PLEURAL EFFUSION AND CIRCUMFERENTIAL PERICARDIAL EFFUSION. CLINICAL CONSEQUENCES: HYPOTENSION AND ANURIA REQUIRING THE INCREASE OF NORADRENALINE (UP TO 0.48 G / KG / MIN) AND INTRODUCTION OF DOBUTAMINE (AT THE MAXIMUM DOSE OF 0.9 G / KG / MIN). LIFE-THREATENING. CATHETER WAS REMOVED AND REPLACED BY A LEFT SUPRACLAVICULAR CATHETER.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT'S CONDITION IS REPORTED AS FINE. HOWEVER, THE PATIENT IS STILL IN THE HOSPITAL BECAUSE OF PREMATURITY. ADDITIONAL INFORMATION: THE X RAY PERFORMED AFTER THE SURGERY DID NOT SHOW A MIGRATION OF THE CATHETER. THE CARDIORESPIRATORY INSUFFICIENCY AND RIGHT PLEURAL EFFUSION AND PERICARDIAL EFFUSION HAS NO LINK WITH THE CONDITION OF THE BABY WHO WAS IN THE RESUSCITATION ROOM FOR A ILEO-COLIC RESECTION THAT FINISHED A STOMA. INTERVENTION: THE INCIDENT LEAD TO A TREATMENT WITH NOREPINEPHRINE (UP TO 0.48 G / KG /MIN) AND DOBUTAMINE (AT A MAXIMUM DOSE OF 0.9 G / KG / MIN). THE CATHETER WAS REMOVED AND PLACEMENT OF A NEW CATHETER IN THE LEFT CLAVICLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: IN THE RESUSCITATION ROOM, CONCERNING A PREMATURE NEW-BORN BABY WHO HAD A SURGERY ON (B)(6) 2018 FOR ILEO-COLIC RESECTION WITH INSERTION OF A STOMA. A PEDIATRIC CVC IS INSERTED IN THE SUPRACLAVICULAR WAY DURING THE INTERVENTION. THE NEWBORN IS THEN SENT TO INTENSIVE CARE. ON (B)(6) 2018, DISCOVERY OF A "PERFUSOTHORAX" (MIGRATION OF THE CATHETER) WITH CARDIORESPIRATORY INSUFFICIENCY. WITH ALSO A RIGHT PLEURAL EFFUSION AND CIRCUMFERENTIAL PERICARDIAL EFFUSION. CLINICAL CONSEQUENCES: HYPOTENSION AND ANURIA REQUIRING THE INCREASE OF NORADRENALINE (UP TO 0.48 G / KG / MIN) AND INTRODUCTION OF DOBUTAMINE (AT THE MAXIMUM DOSE OF 0.9 G / KG / MIN). LIFE-THREATENING. CATHETER WAS REMOVED AND REPLACED BY A LEFT SUPRACLAVICULAR CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357076 ARROW CVC SET: 2-LUMEN 4 FR X 8 CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F17H0453

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R