BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IAB: 8 FR - 30 CC FOS

    MDR report key: 2930420 · Received January 23, 2013

    Report

    Report Number
    1219856-2013-00018
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    November 25, 2012
    Report Date
    January 17, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DSP
    PMA / PMN Number
    K021462
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A FEMALE PT WHILE IN THE INTENSIVE CARE UNIT, APPROX TWO DAYS POST INSERTION WHEN MULTIPLE ALARMS OCCURRED. AN ANGIOGRAM ON (B)(6) 2012 SHOWED NORMAL CORONARY ANATOMY. THE PT WAS PLACED DDD POST OP AND HENCE, WAS IN A REGULAR RHYTHM. INTRA-AORTIC BALLOON PUMP (IABP) THERAPY CONTINUED AS PER MEDICAL ORDERS. THE CARDIOTHORACIC FELLOW MD INSERTED THE INTRA-AORTIC BALLOON (IAB) THROUGH THE SHEATH VIA RIGHT FEMORAL WITHOUT ISSUES. THE STAFF RANG THE (B)(6) AROUND 1415, (B)(6) 2012, TO DISCUSS THE OCCURRENCE OF MULTIPLE "DRAIN/PURGE FAILURE ALARMS" IN THE PRECEDING HOURS. THE FIRST INCIDENCE OF THIS ALARM OCCURRED AROUND 1100-1130; BROWN SPECS WERE FIRST DETECTED IN THE CONDENSATE BOTTLE AROUND 1300-1400. AT THE TIME OF THE PHONE CONVERSATION, THE FLUID IN THE CONDENSATE BOTTLE HAD GONE BROWN AND WAS CONFIRMED BY DIPSTICK TEST TO BE BLOOD. THE CUSTOMER STATED THAT THEY HAD NOT SEEN ANY HELIUM LOSS ALARM DURING THE COURSE OF THE SHIFT LEADING UP TO THE PHONE CALL. (B)(6) ADVISED THE CUSTOMER THAT THE CATHETER SHOULD BE MANAGED AS PER A RUPTURED CATHETER AND THAT THE PRESENCE OF BLOOD IN THE CONDENSATE BOTTLE INDICATES THAT THE PNEUMATIC SYSTEM IS NOW CONTAMINATED. THE DECISION WAS MADE BY THE MEDICAL TEAM TO CONTINUE IABP THERAPY WITH THE CURRENT IAB INSITU. THE MEDICAL TEAM MADE THE DECISION BASED ON THE ABSENCE OF HELIUM LOSS ALARM, NORMAL LOOKING BALLOON PRESSURE WAVEFORM (BPW), APPROPRIATE AUGMENTATION AND ABSENCE OF BLOOD/CLOTS IN THE GAS DRIVELINE. THE (B)(6) MADE A CUSTOMER VISIT ON THE FOLLOWING DAY, (B)(6) 2012. DURING THAT VISIT, IT WAS IDENTIFIED THAT THE GAS DRIVELINE PROXIMAL TO THE IABP (AUTOCAT2 WAVE, SERIAL #(B)(4)) WAS RIDDLED WITH SIGNIFICANT SPOTTING (CLOTS). THE TEAM LEADER INDICATED THAT THE IAB HAD BEEN REPOSITIONED UP TO 4 TIMES ON (B)(6). THE (B)(6) ADVISED THE CUSTOMER THAT THERE WAS A VERY SIGNIFICANT RISK THAT THE IAB HAD RUPTURED DUE TO THE PRESENCE OF BLOOD IN THE GAS DRIVELINE AND THAT IT SHOULD BE REMOVED. THE CUSTOMER DECIDED TO CONTINUE WITH THE CURRENT THERAPY WITH THE PLAN TO REMOVE THE IAB THE FOLLOWING DAY. THE (B)(6) TOOK A NUMBER OF PHOTOS OF THE CONDENSATE VIA AND GAS DRIVELINE WITH THE CUSTOMERS PERMISSION. A TIMING STRIP WITH ARTERIAL PRESSURE (AP) AND BPW WAS ALSO OBTAINED WITH PERMISSION. THE CUSTOMER WAS ADVISED ON THE RISK OF IAB ENTRAPMENT DUE TO CLOT FORMATION IN THE IAB AND IT MAY REQUIRE SURGICAL INTERVENTION TO REMOVE THE IAB. THE CUSTOMER INDICATED THEY UNDERSTOOD THE RISK. BPW AND AP STRIPS ARE INCLUDED PRIOR TO ANY EVIDENCE OF GAS ALARMS AND PRIOR TO REPOSITIONING OF THE IAB. ONCE THERAPY WAS CEASED, THE IAB APPEARED TO HAVE SUSTAINED AN ABRASION AND THEREFORE, THE IAB WAS NOT ABLE TO REMOVED IN THE INTENSIVE CARE UNIT (ICU). AS A RESULT, SURGICAL REMOVAL HAD TO BE PERFORMED. A LAPAROTOMY WAS PERFORMED TO ACCESS THE TIP OF THE IAB IN WHICH RESIDED A LARGE CLOT WHICH PREVENTED EXTRACTION THROUGH THE FEMORAL ARTERY. A DACRON PATCH WAS PLACED ON THE PT'S AORTA. THERE WAS NO REPORT OF PT DEATH OR COMPLICATIONS. THERE WAS A DELAY OR INTERRUPTION IN THERAPY. THE PT OUTCOME IS THE PT REMAINED IN A CLINICAL SITUATION THAT WAS SATISFACTORY TO THE MEDICAL AND NURSING TEAMS AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31975 IAB: 8 FR - 30 CC FOS INTRA-AORTIC BALLOON FIBER OPTIC SYSTEM (FOS) DSP ARROW INTERNATIONAL INC KF1121993

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention INTRA-AORTIC BALLOON PUMP