BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW

    MDR report key: 13174933 · Received January 6, 2022

    Report

    Report Number
    13174933
    Event Type
    Injury
    Date Received
    January 6, 2022
    Date of Event
    December 27, 2021
    Report Date
    December 30, 2021
    Manufacturer
    TELEFLEX INCORPORATED
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT IN CICU (CARDIAC INTENSIVE CARE UNIT) WITH IABP (INTRA-AORTIC BALLOON PUMP) AFTER CARDIAC CATH PROCEDURE 2 DAYS EARLIER. HELIUM LOSS ALARMS BEGAN AT APPROXIMATELY 1800, BLOOD NOTED IN HELIUM TUBING. THE ATTENDING MD INTENSIVIST, RESIDENT, AND PERFUSIONIST WERE AT BEDSIDE CONFIRMED IABP RUPTURE. THE PATIENT'S BP INITIALLY STABLE WITH PUMP OFF BUT SHORTLY AFTER BECAME HYPOTENSIVE REQUIRING IV INFUSIONS OF EPINEPHRINE AND LEVOPHED. THE ATTENDING MD MET DIFFICULTY WITH REMOVING THE IABP CATHETER. VASCULAR SURGERY CALLED TO BEDSIDE AND WAS ABLE TO SUCCESSFULLY EXTRACT IABP WITH SHEATH WITHOUT ANY DIFFICULTIES WITHIN 15 MINUTES. PATIENT'S BP DOWN TRENDING AND FAMILY CALLED TO COME TO BEDSIDE. PATIENT DIED WITHIN THE HOUR OF REMOVAL OF IABP. MANUFACTURER RESPONSE FOR SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL, ARROW (PER SITE REPORTER).

    Description of Event or Problem · 0

    PATIENT IN CICU (CARDIAC INTENSIVE CARE UNIT) WITH IABP (INTRA-AORTIC BALLOON PUMP) AFTER CARDIAC CATH PROCEDURE 2 DAYS EARLIER. HELIUM LOSS ALARMS BEGAN AT APPROXIMATELY 1800, BLOOD NOTED IN HELIUM TUBING. THE ATTENDING MD INTENSIVIST, RESIDENT, AND PERFUSIONIST WERE AT BEDSIDE CONFIRMED IABP RUPTURE. THE PATIENT'S BP INITIALLY STABLE WITH PUMP OFF BUT SHORTLY AFTER BECAME HYPOTENSIVE REQUIRING IV INFUSIONS OF EPINEPHRINE AND LEVOPHED. THE ATTENDING MD MET DIFFICULTY WITH REMOVING THE IABP CATHETER. VASCULAR SURGERY CALLED TO BEDSIDE AND WAS ABLE TO SUCCESSFULLY EXTRACT IABP WITH SHEATH WITHOUT ANY DIFFICULTIES WITHIN 15 MINUTES. PATIENT'S BP DOWN TRENDING AND FAMILY CALLED TO COME TO BEDSIDE. PATIENT DIED WITHIN THE HOUR OF REMOVAL OF IABP. MANUFACTURER RESPONSE FOR SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL, ARROW (PER SITE REPORTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616651 ARROW SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP TELEFLEX INCORPORATED IPN915317 18F21H0047

    Patients

    Seq Age Sex Outcome Treatment
    1 33945 DA Female Life Threatening| R