BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    120V AUTOCAT IAB PUMP

    MDR report key: 1030676 · Received April 15, 2008

    Report

    Report Number
    1219856-2008-00190
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Date of Event
    March 21, 2008
    Report Date
    April 15, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K983866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: NO PARTS WERE RETURNED FOR EVAL. THE INTRA-AORTIC BALLOON PUMP WAS CHECKED BY ARROW FIELD SERVICE. THE FILL PRESSURE WAS CHECKED AND FOUND TO BE IN SPECIFICATION. THE PUMP WAS CONNECTED TO A SIMULATOR AND RAN FOR APPROXIMATELY ONE AND A HALF HOURS AT VARIOUS HEART RATES UP TO 160BPM, VARIOUS SIMULATED HEART RHYTHMS AND VARIOUS TRIGGER MODES. THE PROBLEM COULD NOT BE DUPLICATED. A CHECK OF THE SERVICE RECORDS FOR THIS PUMP SHOWED THAT IT EXPERIENCED A FILL PRESSURE ALARM ONE OTHER TIME. IT OCCURRED ONE MONTH PRIOR TO THIS EVENT. BIOMED CHECKED THE PUMP AT THAT TIME AND FOUND THE HELIUM TANK WAS IMPROPERLY SEATED. ONCE THE TANK WAS PROPERLY SEATED THE ISSUE WAS RESOLVED. A DEVICE HISTORY RECORD RE-REVIEW WAS CONDUCTED ON THE REPORTED PUMP AND IT MET ALL SPECIFICATIONS AND PASSED ALL IN-PROCESS TESTING. THERE WERE NO MANUFACTURING ABNORMALITIES ESTABLISHED BETWEEN THE DEVICE HISTORY RECORD AND THE REPORTED COMPLAINT. THE COMPLAINT COULD NOT BE DUPLICATED THROUGH TESTING BY ARROW FIELD SERVICE. MANAGEMENT WILL CONTINUE MONITORING COMPLAINT REPORTS FOR ANY TRENDS WHICH MAY APPEAR.

    Description of Event or Problem · 1

    EVENT WAS RECEIVED BY CALL REPORT. IT WAS REPORTED THAT THE PROCEDURE WAS BEING PERFORMED ON A MALE PATIENT (PT.) THAT HAD AN INTRA-AORTIC BALLOON (IAB) PLACED IN THE CATH LAB IN 2008, AND WAS SCHEDULED FOR CORONARY ARTERY BYPASS GRAFT SURGERY IN THE FOLLOWING MONDAY. REGISTERED NURSE HAD CALLED IN BECAUSE THEY RECEIVED A "GAS LOSS" ALARM. PT. WAS CURRENTLY IN A SINUS RHYTHM WITH OCCASIONAL PREMATURE ATRIAL CONTRACTIONS (PAC). TUBING WAS CHECKED FOR SIGNS OF BLOOD AND THERE WAS NONE; ALL CONNECTIONS WERE CHECKED AND WERE TIGHT. PT. WAS NOT MOVING WHEN ALARM OCCURRED. INSERTION WAS LESS THAN A 45 DEGREE ANGLE. CLINICIAN STATED BALLOON PRESSURE WAVEFORM (BPW) SOMETIMES LOOKS LIKE THE CHAIR AND THEN GOES AWAY. CLINICIAN FAXED A STRIP TO CLINICAL ON CALL AND BPW DID NOT DISPLAY A PLATEAU. AUTOPILOT HAD PULLED DEFLATION IN EARLY. CLINICAL SUPPORT SPECIALIST (CSS) ASKED IF DEFLATION TIMING APPEARED TO BE SLIGHTLY EARLY AND CLINICIAN STATED THAT IT DID. CSS EXPLAINED SHE FELT IT WAS MOST LIKELY DUE TO A PARTIAL KINK. WHEN PT. HAD AN EARLY BEAT (PAC) THE PUMP WAS NOT ABLE TO ASSESS BASELINE OF BPW AND THEREFORE, GAVE HIM "GAS LOSS" ALARM. CSS SUGGESTED THEY REPOSITION PT., ADDING TRACTION TO CATHETER, HYPEREXTENDING HIP, AND CHECKING X-RAY FOR POSITION. MOST LIKELY PARTIAL KINK IS INTERNAL. CSS EXPLAINED THEY MAY GET SOME OCCASIONAL "GAS LOSS" ALARMS WHEN PT HAS AN EARLY BEAT. CSS RECEIVED ANOTHER CALL FROM CLINICIAN AN HOUR LATER AND REPORTED THEY WERE GETTING CONSTANT "FILL FAILURE" ALARMS. CSS EXPLAINED PUMP IS UNABLE TO FILL TO ZERO NOW AND KINK MUST BE SIGNIFICANT ENOUGH THAT IT CANNOT FUNCTION. CLINICIAN STATED MD WAS ON THE WAY IN TO EXCHANGE IAB. CSS HAD CLINCIAN TRY DECREASING IAB VOLUME TO 35 AND THEN TO 32, BUT NEITHER OF THESE MADE ANY DIFFERENCE. PT. WAS STABLE AT PRESENT. MD DID NOT CHANGE OUT IAB. INSTEAD THEY CHANGED PUMP; SECOND PUMP DID NOT HAVE ALARMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 120V AUTOCAT IAB PUMP INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK