BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTA WASH SET COD. 740E/225

    MDR report key: 2008892 · Received March 1, 2011

    Report

    Report Number
    1718850-2011-00009
    Event Type
    Death
    Date Received
    March 1, 2011
    Date of Event
    October 18, 2008
    Report Date
    October 20, 2008
    Manufacturer
    SORIN GROUP ITALIA
    Product Code
    CAC
    PMA / PMN Number
    K020647
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE ELECTA AUTOTRANSFUSION MACHINE. THE INCIDENT OCCURRED IN (B)(4). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). PLEASE NOTE THAT THIS MDR IS BEING FILED LATE AS A RESULT OF A CHANGE IN SORIN GROUP (B)(4) COMPLAINT REPORTING CRITERIA AND SUBSEQUENT REVIEW OF THE PAST COMPLAINTS TO THESE CRITERIA. DURING AN AORTIC STENT INSERTION, THE CATHETER GUIDE ENHANCED THE DISSECTION, LEADING TO INTRATHORACIC BLEEDING. THE NURSE AND ANESTHESIOLOGIST SET UP THE AUTOTRANSFUSION MACHINE, LOADING THE RESERVOIR AND WASH SET. AFTER COLLECTING APPROX 1.5 LITERS OF BLOOD, THE MACHINE GAVE AN "AIR IN LINE" ALARM. IT WAS DETERMINED THAT THE WASH SET CASSETTE HAD BEEN PLACED INCORRECTLY, DAMAGING THE PUMP LOOP. A BACKUP WASH SET WAS NOT AVAILABLE. THE AUTOTRANSFUSION MACHINE WAS TURNED OFF. THE PT REPORTEDLY EXPIRED DUE TO A NON-MANAGEABLE SITUATION DUE TO HIS GENERAL ILLNESS. AN ELECTA MACHINE FROM INVENTORY WAS USED TO RE-CREATE THE SCENARIO DESCRIBED BY THE REPORT. TESTING SHOWED THAT INCORRECT PLACEMENT OF A WASH SET CASSETTE CAN RESULT IN THE ISSUES EXPERIENCED BY THE CUSTOMER. THE DAMAGED PUMP LOOP TUBING WAS RETURNED TO SGI FOR EVAL. THE DAMAGE OBSERVED ON THE RETURNED SEGMENT IS COMPARABLE TO THAT PRODUCED DURING THE TESTING ON PRODUCT FROM INVENTORY DESCRIBED ABOVE. THE ELECTA INSTRUCTIONS FOR USE INSTRUCT THE USER ON PROPER INSERTION TECHNIQUES AND STATE THAT "INCORRECT POSITIONING (INCOMPLETE INSERTION) OF THE CASSETTE ON THE CROSS-SHAPED BLACK HOUSING MAY DAMAGE PUMP SEGMENT DURING AUTOMATIC LOADING." AND "INCORRECT POSITIONING OF THE TUBING INSIDE THE BUBBLE SENSOR MAY CAUSE MALFUNCTIONS AND, CONSEQUENTLY, ERROR MESSAGES." SORIN GROUP (B)(4) CONCLUDED THAT WRONG POSITIONING OF THE CASSETTE DURING THE MACHINE SETUP CAUSED THE WEARING AND DAMAGE OF THE PUMP LOOP. THE INCORRECT MANAGEMENT OF THE WARNINGS AND ALARMS DUE TO THE MIS-POSITIONING OF THE CASSETTE IMPEDED THE ABILITY TO PROCESS THE PT'S BLOOD. THE FACILITY REPORTED THE INCIDENT TO THE COUNTRY'S COMPETENT AUTHORITY. AN ALLEGATION OF PT CONSEQUENCE DUE TO THE INCIDENT WAS INDICATED ON THE REPORT. THIS MEDWATCH REPORT IS BEING FILED AS A RESULT OF THESE ACTIONS.

    Description of Event or Problem · 1

    DURING AN AORTIC STENT INSERTION, THE CATHETER GUIDE ENHANCED THE DISSECTION, LEADING TO INTRATHORACIC BLEEDING. THE NURSE AND ANESTHESIOLOGIST SET UP THE AUTOTRANSFUSION MACHINE. THE MACHINE DID NOT ALARM DURING SET UP. AFTER COLLECTING APPROX 1.5 LITERS OF BLOOD, THE MACHINE GAVE AN "AIR IN LINE" ALARM. IT WAS DETERMINED THAT THE WASH SET CASSETTE HAD BEEN PLACED INCORRECTLY, DAMAGING THE PUMP LOOP. A BACKUP WASH SET WAS NOT AVAILABLE. THE AUTOTRANSFUSION MACHINE WAS TURNED OFF. UP TO 4 LITERS OF BLOOD WERE COLLECTED IN AUTOTRANSFUSION RESERVOIRS FROM THE PT'S THORAX, BUT WAS NOT PROCESSED. THE PT WAS GIVEN PACKED CELLS, FFP AND COLLOID. IT WAS REPORTED THAT THE PT EXPIRED DUE TO A NON MANAGEABLE SITUATION DUE TO HIS GENERAL ILLNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTA WASH SET COD. 740E/225 AUTOTRANSFUSION DEVICE CAC SORIN GROUP ITALIA NA 0806040275

    Patients

    Seq Age Sex Outcome Treatment
    1 Death