BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IAB : 8 FR - 30 CC FOS

    MDR report key: 2150524 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00220
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 21, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER CONTROL NO (B)(4). FOLLOW-UP REPORT WILL BE FILED, IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED PER CALL REPORT, TIME 0411 HOURS, THAT A FEMALE PATIENT (PT) IN THE CTU (CARDIAC THORACIC UNIT) HAD AN INTRA-AORTIC BALLOON (IAB) INSERTED IN THE FEMORAL ARTERY FOR GREATER THAN 24 HOURS. THE PUMP (IAP-0500 S/N (B)(4)) ALARMED "HIGH PRESSURE ALARM" AFTER THE PT BEGAN THRASHING IN THE BED AND BENDING HER LEGS. THE NURSE STRAIGHTENED THE PT'S LEG AND SEDATED THE PT HOWEVER, THE PUMP CONTINUED TO ALARM. THE RN WAS INSTRUCTED BY THE CLINICAL SUPPORT SPECIALIST (CSS) TO PRESS THE "RESET BUTTON" AND THE "GREEN ON BUTTON." THE PUMP DID NOT START PUMPING AGAIN AND IMMEDIATELY STARTED ALARMING "HIGH PRESSURE." THE RN TRIED A TOTAL OF TWO TIMES TO RESET AND START THE PUMP WITH THE SAME RESULTS. AT THIS TIME, THE CSS ASKED THE RN TO POWER THE PUMP DOWN AND THEN BACK ON. THE PUMP BEGAN PUMPING AFTER THE RN PRESSED THE ON BUTTON, HOWEVER, ONLY FOR A VERY SHORT PERIOD OF TIME. THE CSS GAVE THE RN TROUBLESHOOTING TIPS ON HOW TO ALLEVIATE THE KINK AND THE RN PLANNED TO CALL THE FELLOW TO SEE IF HE WANTED TO DISCONTINUE THE IAB; PT. WAS ON 1:2. THE CALL ENDED. AT 0544 HOURS, THE CSS RECEIVED A TEXT MESSAGE ON HER PHONE STATING THE FELLOW DISCONTINUED THE IAB. ACCORDING TO THE RN, THE CATHETER LOOKED LIKE IT HAD NOT BEEN INFLATING, THE HIGH PRESSURE ALARM THAT PROMPTED THE CALL WAS THE FIRST ALARM THEY RECEIVED. THE IAB WAS REMOVED AND IT IS UNKNOWN IF IT WAS REPLACED. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. THE PATIENT REMAINED STABLE THROUGHOUT THE CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB : 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN