BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TPE SET, SPECTRA

    MDR report key: 1951887 · Received December 29, 2010

    Report

    Report Number
    1722028-2010-00119
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    June 5, 2010
    Report Date
    December 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) POSSIBLE HEMOLYSIS. THE PT IS STABLE AND STILL RECEIVES RESPIRATORY CARE. THE PT DID NOT RECEIVE TREATMENT SPECIFIC TO THE HEMOLYSIS. THE PT REC'D ETOMIDATE (SEDATIVE) BEFORE THE INTUBATION. DURING F/U, THE CUSTOMER STATED THAT SINCE THE INCIDENT, THEY HAVE PERFORMED TWO PROCEDURES ON THE SAME PT WITHOUT ANY PROBLEMS AND IT WOULD NOT BE NECESSARY TO CHECK THE MACHINE. THIS DISPOSABLE SET WAS UNAVAILABLE FOR RETURN FOR INVESTIGATION. HEMOLYSIS CAN OCCUR DUE TO MANY FACTORS OUTSIDE OF CARIDIANBCT'S CONTROL; STORAGE/TEMPERATURE CONDITIONS, OPERATOR HANDLING (MECHANICAL FORCES), INCORRECT SOLUTION / MEDICATION / CHEMICAL ADDITION, ETC. THERE IS CURRENTLY NO EVIDENCE THAT INDICATE THAT THE PRODUCT DID NOT MEET PERFORMANCE SPECIFICATION. PER THE PHYSICIAN, HEMOLYSIS MIGHT HAVE BEEN CAUSED BY THE MEDICATION THE PT REC'D. ALTHOUGH, LITERATURE DOES NOT SUPPORT THAT ETOMIDATE MAY CAUSE OR CONTRIBUTE TO HEMOLYSIS, THIS CAUSE AND EFFECT SPECULATION IS SUPPORTED BY THE TIMING OF THE EVENTS. ETOMIDATE ACTS USUALLY WITHIN 1 MINUTE (REFERENCE - AMIDATE PACKAGE INSERT, ABBOTT / US, REV 5/97, REC 4/99) OF INTRODUCTION AND HEMOLYSIS WAS NOT OBSERVED BY THE OPERATOR UNTIL THIS DRUG WAS INTRODUCED TO THE PT. SINCE THE TUBING SET WAS NOT RETURNED FOR ANALYSIS, A DEFINITIVE CONCLUSION CANNOT BE DRAWN. PRE AND POST PROCEDURE HEMOGLOBIN VALUES DO NOT SUGGEST EXTENSIVE HEMOLYSIS.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVALUATION PROCESS. WE HAVE CHANGED OUR PROCESS TO BETTER ALIGN WITH CURRENT AGENCY POLICY. THE FOLLOWING INCIDENT DESCRIPTION WAS PROVIDED TO CARIDIANBCT QUALITY ASSURANCE: MG PT WAS ADMITTED WITH BREATHING DIFFICULTIES (PRE-CONDITION). SCHEDULED FOR THYMECTOMY AND 5 TPE PROCEDURES BEFORE SURGERY. THE PT NEEDED TO BE INTUBATED MORE THAN HALF WAY THROUGH THE TPE PROCEDURE. AT WHICH POINT, THE OPERATOR NOTICED LIGHT HEMOLYSIS IN CENTRIFUGE, PLASMA LINE AND WASTE BAG (NO ALARM NOTED). THE OPERATOR STATED THAT THE HEMOLYSIS WENT ON FOR 2 MINUTES. THE OPERATOR THAN ABORTED THE PROCEDURE AND DID NOT PERFORM RINSEBACK. THIS REPORT IS BEING SUBMITTED DUE TO THE POTENTIAL FOR INJURY AND TERMINATION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TPE SET, SPECTRA SEPARATOR, AUTOMATED, BLOOD CELL AND PL LKN CARIDIANBCT NA 02S15276

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other