BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 2990342 · Received March 5, 2013

    Report

    Report Number
    1722028-2013-00986
    Date Received
    March 5, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 5, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK120012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. PER AN INTERNAL RISK ASSESSMENT, TRANSFUSION REACTIONS MAY OCCUR IN AS MANY AS (B)(4) OF PROCEDURES. THE USE OF FRESH FROZEN PLASMA (FFP) AS THE REPLACEMENT FLUID INCREASES THE RATE OF REACTIONS. THE MAJORITY OF THESE REACTIONS ARE MILD AND WELL TOLERATED. PER THE CUSTOMER, THE PATIENT HAS HAD MULTIPLE TPE PROCEDURES USING FFP AS THE REPLACEMENT FLUID AND HAS A HISTORY OF OCCASIONAL NON-FEBRILE ALLERGIC REACTIONS OCCURRING WITH THE TPE PROCEDURES. THE PHYSICIAN STATES THE REACTION IS DUE TO THE FFP REPLACEMENT FLUID. THE PATIENT WAS NOT PRE-MEDICATED FOR THE PROCEDURE. ROOT CAUSE: BASED ON THE PATIENT'S HISTORY, THE REACTION WAS DUE TO A KNOWN ALLERGY TO FRESH FROZEN PLASMA (FFP). BASED ON THE EVALUATION OF THE RETURNED DISPOSABLE SET, THE LEAK IN THE CHANNEL WAS DUE TO INCOMPLETE SEATING OF THE CHANNEL IN THE FILLER PLATE OF THE MACHINE. IF THE CHANNEL IS NOT FULLY SEATED, THE CHANNEL WILL BEGIN TO LIFT OUT OF THE FILLER PLATE DURING CENTRIFUGATION. AS THE CHANNEL LIFTS, IT RUBS AGAINST THE CENTRIFUGE ARM, WHICH SHEARS OFF THE CHANNEL MATERIAL. THIS RESULTS IN THE MARKS SEEN ON THE CHANNEL AND ULTIMATELY CAUSES A LEAK.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS RETURNED FOR EVALUATION. THE LEAK IN THE CHANNEL WAS LOCATED ON THE TOP EDGE OF THE CHANNEL NEAR THE INLET CONNECTOR. THE CORNER OF THE CHANNEL WAS WORN OFF NEAR THE INLET CONNECTOR AND A WITNESS LINE WAS OBSERVED AS WELL, INDICATING A CHANNEL MISLOAD. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE THERAPEUTIC PLASMA EXCHANGE PROCEDURE HAD ENDED DUE TO A LEAK IN THE DISPOSABLE SET. TEN MINUTES AFTER THE PROCEDURE HAD ENDED, THE PATIENT DEVELOPED 3-4 HIVES AND ITCHING ON HER EYELIDS AND FACE. SHE HAD NO OTHER SYMPTOMS AND SHE DID NOT HAVE ANY CHANGES IN HER BP OR PULSE. THE PHYSICIAN DETERMINED THAT THE PATIENT HAD A NON-FEBRILE ALLERGIC REACTION TO THE REPLACEMENT FRESH FROZEN PLASMA THAT WAS USED FOR THE PROCEDURE. THE PATIENT WAS GIVEN 25 MG OF IV BENADRYL. SHE DID NOT RECEIVE ANY OTHER MEDICATIONS OR FLUIDS. THE NURSE CHECKED ON THE PATIENT TWICE MORE DURING THE DAY AND THE PATIENT HAD COMPLETE RESOLUTION OF THE HIVES AND NO FURTHER PROBLEMS. PATIENT IDENTIFIER IS NOT AVAILABLE FROM THE CUSTOMER DUE TO PRIVACY RULES. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION IN THE FORM OF IV BENADRYL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94192 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 01V3202

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Other