BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE JAPANESE

    MDR report key: 3050194 · Received April 5, 2013

    Report

    Report Number
    1219856-2013-00083
    Event Type
    Malfunction
    Date Received
    April 5, 2013
    Date of Event
    March 18, 2013
    Report Date
    April 4, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A MALE PATIENT WHILE IN THE CATH LAB. THE ZEON MEDICAL INTRA-AORTIC BALLOON (IAB) WAS INSERTED WITH NO ISSUES. RIGHT AFTER THE INTRA-AORTIC BALLOON PUMP (IABP), S/N (B)(4), WAS STARTED A SYSTEM ERROR 3 OCCURRED. THE USER RESTARTED THE IABP, BUT SYSTEM ERROR 3 OCCURRED AGAIN AFTER 10 MINUTES. AS A RESULT, THE USER SWITCHED OUT THE PUMP FOR A NON ARROW IABP. THE ZEON MEDICAL IAB WAS LEFT IN PLACE. THERE WAS NO REPORT OF PATIENT DEATH, COMPLICATIONS OR INJURY. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A DELAY OR INTERRUPTION IN THERAPY, JUST LONG ENOUGH TO SWITCH THE IABP'S OUT WITH NO HARM TO THE PATIENT. THE PATIENT OUTCOME IS GOOD. THE PUMP WILL BE INSPECTED BY TELEFLEX (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139911 AUTOCAT 2 WAVE JAPANESE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON PUMP (BRAND UNK)| ZEON INTRA-AORTIC BALLOON