BEUDAMED
    FDA Adverse Event Other Summary report: N

    COBE SPECTRA TPE SET

    MDR report key: 1890834 · Received October 28, 2010

    Report

    Report Number
    1722028-2010-00035
    Event Type
    Other
    Date Received
    October 28, 2010
    Date of Event
    April 14, 2010
    Report Date
    October 29, 2010
    Manufacturer
    CARIDIANBCT
    Product Code
    LKN
    PMA / PMN Number
    K9000105
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A SIMULATED RUN WAS PERFORMED ON (B)(6) 2010 USING A TPE SET. CARIDIANBCT INVESTIGATORS COULD NOT CREATE THE CONDITION BY MISLOADING THE PLASMA VALVE TUBING BECAUSE THE SET WOULD NOT PASS ALARM TESTS. IF THE PLASMA COLLECT LINE ON A COBE SPECTRA DISPOSABLE IS BLOCKED DURING A TPE PROCEDURE, THIS CAN RESULT IN HYPERVOLEMIA IN THE PATIENT. IN THE PAST, CARIDIANBCT COMPLAINT INVESTIGATORS RAN THE SAME TYPE OF DISPOSABLE SET WITH THE COLLECT LINE BLOCKED. THE LACK OF ALARM IS LIKELY BECAUSE AN OCCLUSION AT THIS SITE ON THE PLASMA LINE DOES NOT RESULT IN INCREASED PRESSURE WITHIN THE TUBING SET BECAUSE THERE IS AN OPEN PATH VIA THE RBC RETURN LINE. IT HAS BEEN SHOWN THAT MISLOADING OF THE DISPOSABLE TUBING BELOW THE CCM CAN CAUSE AN INDENTATION SEVERE ENOUGH TO CREATE AN OCCLUSION. ROOT CAUSE: ALTHOUGH THE SET WAS RETURNED FOR INVESTIGATION, NO ROOT CAUSE COULD BE DETERMINED. IT IS LIKELY THAT THE ROOT CAUSE OF THIS INCIDENT IS RELATED TO AN OCCLUSION IN THE PLASMA COLLECT TUBING LINE THAT SELF-CORRECTED DURING THE PROCEDURE AS EVIDENCED BY SOME PLASMA WASTE BEING COLLECTED. IT IS UNCONFIRMED WHETHER THIS BLOCKAGE WAS PRODUCED BY A MFG DEFECT OF THE COBE SPECTRA DISPOSABLE OR BY THE WAY THE DISPOSABLE WAS LOADED AND HANDLED AT THE CUSTOMER SITE. SAFETY RISK ASSESSMENT: POST-PROCEDURE, THE PATIENT WAS WELL WITHOUT MEDICAL INTERVENTION TO TREAT THE HYPERVOLEMIA.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS A RESULT OF CHANGES TO OUR MDR EVAL PROCESS THAT WERE PROMPTED BY AN FDA INSPECTION. AT THE END OF A TPE PROCEDURE, THE OPERATOR NOTED THAT THE REMOVED VOLUME IN THE WASTE BAG WAS SIGNIFICANTLY LESS THAN IT SHOULD BE. THE PATIENT DID TOLERATE THE PROCEDURE WELL. PRE BP 139/74, PULSE 75 - POST BP 139/66 PULSE 93. PER THE CUSTOMER, THE PATIENT DID NOT HAVE ANY RESPIRATORY DISTRESS OR OTHER SYMPTOMS OF FLUID OVERLOAD. THE DISPLAYED REMOVE VOLUME WAS 3516ML (INCLUDING 374ML OF AC). THE ACTUAL PROCEDURE VOLUMES ARE AS FOLLOWS: REMOVED VOL = 1300ML, REPLACED = 3084ML 5% ALBUMIN PLUS 195ML RINSEBACK SALINE. THE CUSTOMER STATED THE PATIENT IS STABLE AND DID NOT REQUIRE ANY MEDICAL INTERVENTION AS A RESULT OF THIS FLUID IMBALANCE WITH THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COBE SPECTRA TPE SET SEPARATOR, AUTOMATED, BLOOD CELL AND PLATELETS LKN CARIDIANBCT 950000000 03S15202

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other