BEUDAMED
    FDA Adverse Event Summary report: N

    AUTOCAT 2

    MDR report key: 2945150 · Received January 31, 2013

    Report

    Report Number
    1219856-2013-00024
    Date Received
    January 31, 2013
    Date of Event
    December 26, 2012
    Report Date
    January 30, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PT, WITH LENGTH OF TIME INTRA-AORTIC BALLOON PUMP (IABP) IN USE PRIOR TO EVENT, 15 HOURS. WHILE IN THE DSA (CATHETER ROOM), THE INTRA-AORTIC BALLOON (IAB) WAS INSERTED SHEATHLESS VIA THE PT'S LEFT FEMORAL ARTERY. AFTER INSERTION, THE MACHINE FAILED TO TURN ON WITH LONG TIME ALARM. THE IABP WAS EXCHANGED OFF THE PT. THERE WAS NO REPORTED PT DEATH, INJURY OR COMPLICATIONS. THERE WAS A REPORTED 1 HOUR DELAY IN IABP THERAPY. THE ENGINEER BROUGHT A NEW IABP TO THE CUSTOMER. THE PT OUTCOME IS LISTED AS "WELL." THE ENGINEER TOOK THE MACHINE APART AND FOUND THE BATTERY VOLTAGE WAS 10.6V (NORMAL VOLTAGE: 11.7V) AND THE CHARGING VOLTAGE WAS 10.6V (NORMAL RANGE: 13.5V-14.1V). THE ENGINEER REPLACED THE POWER SUPPLY ON THE IABP (S/N (B)(4)) WITH A NEW ONE. THE IABP WAS THEN WORKING NORMALLY AND OUTPUT VOLTAGE WAS IN NORMAL RANGE. THE POWER SUPPLY WAS CONFIRMED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 BY THE QUALITY ENGINEER STATED THAT "DSA MEANS CATHETER ROOM. THE IAB WAS INSERTED AND THE PT RECEIVED IABP THERAPY FOR 15 HOURS, THEN POWERED OFF AND FAILED TO TURN ON." FURTHER INFORMATION RECEIVED ON (B)(6) 2013, STATED THAT THE PUMP WAS ON AC AT THE TIME OF THE EVENT. AN UPDATE RECEIVED ON (B)(6) 2013, STATED THAT AFTER THE MALFUNCTION HAPPENED, THE IAB WAS DEFLATING. THE DOCTOR USED THE SYRINGE TO CONDUCT INFLATION AND DEFLATION SEVERAL TIMES WITHIN 1 HOUR FOR THE PURPOSE OF PREVENTING THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42987 AUTOCAT 2 INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR