BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2

    MDR report key: 1818208 · Received August 20, 2010

    Report

    Report Number
    1219856-2010-00543
    Event Type
    Malfunction
    Date Received
    August 20, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DISTRIBUTOR'S ENGINEER INSPECTED THE PUMP AND FOUND THAT THE PROBLEM WAS THE FRONT END PRINTED CIRCUIT BOARD (PCB). AS A RESULT, THE ENGINEER REPLACED THE FRONT END PCB AND AFTERWARD THE PUMP WORKED WELL. THIS IABP IS UNDER WARRANTY AND WAS DELIVERED TO THE HOSPITAL ON (B)(6) 2009.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED THROUGH A SHEATH INTO THE PATIENT'S LEFT FEMORAL ARTERY. WHILE IN THE CARDIO CATH LAB, THE MONITOR DISPLAYED "LOW ARTERIAL PRESSURE" CONTINUOUSLY. AS TIME WENT BY, THE PATIENT PRESSURE DID NOT RETURN TO NORMAL RANGE AND KEPT FALLING. THEREFORE, THE MD CALLED THE DISTRIBUTOR'S ENGINEER FOR SERVICE. THE ENGINEER INVESTIGATED THE INTRA-AORTIC BALLOON PUMP (IABP) RIGHT AWAY AND REPLACED THE IABP WITH A DEMO UNIT FROM THE DISTRIBUTOR. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. IT WAS REPORTED THAT THERE WAS A TWO HOUR DELAY/INTERRUPTION IN IABP THERAPY. THE PATIENT OUTCOME IS RECORDED AS "THE PATIENT DOES NOT HAVE ANY COMPLICATIONS AND IS FINE." THERE ARE NO STRIPS AVAILABLE FOR REVIEW. ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE ON 8/9/2010 STATED THAT ACCORDING TO THE HOSPITAL MD, THE PATIENT ARTERIAL PRESSURE (AP) STARTED FALLING A FEW MINUTES AFTER IAB CATHETERIZATION. HOWEVER, THERE WAS NO DELAY OR INTERRUPTION TO THE COUNTERPULSATION THERAPY AS THE IABP WAS TRIGGERED BY KEG. THE PATIENT WAS NOT INJURED BY THE PROCEDURE, BUT THE MD HAD TO HAVE A CLOSE LOOK AT THE HEMODYNAMIC PARAMETERS WHILE CHECKING THE PRESSURE USING ADDITIONAL MONITOR. DELAY IN THERAPY TOOK ALMOST TWO HOURS (MD DOUBTED IABP FUNCTION DUE TO GETTING LOWERED AP OBTAINED FROM IABP). WE REPLACED IT WITH OUR OWN PUMP, OUR SERVICE TEAM ANALYZED AND FOUND OUT THE SOURCE OF PROBLEM. THE PATIENT BENEFITED FROM THE IAB THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT 2 INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN INTRA-AORTIC BALLOON