BEUDAMED
    FDA Adverse Event Other Summary report: N

    PLASMACELL C DISPOSABLE SET SPIKESMART

    MDR report key: 511531 · Received January 16, 2004

    Report

    Report Number
    1420141-2004-00002
    Event Type
    Other
    Date Received
    January 16, 2004
    Date of Event
    October 2, 2003
    Report Date
    October 21, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    GKT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    INITIAL NOTIFICATION OF EVENT WAS RECEIVED BY PRODUCT SURVEILLANCE IN 11/2003 FROM BIOLIFE PLASMA SERVICES GROUP. THE REPORT STATED THAT IN 2003 THE DONOR INFORMED AN EMPLOYEE AT THE CENTER THAT AFTER RETURNING HOME FROM DONATING PLASMA DONOR DEVELOPED THE FOLLOWING SYMPTOMS: WEAKNESS, NAUSEA, DIZZINESS AND BLOOD IN THEIR URINE. THE CENTER MEDICAL DIRECTOR WAS NOTIFIED AND HE ADVISED CENTER TO DIRECT THE DONOR TO DRINK LARGE AMOUNTS OF FLUIDS FOR THE DAY. TWO MONTHS LATER FOLLOW-UP INFO WAS OBTAINED BY PRODUCT SURVEILLIANCE REGARDING THE ATTEMPTED PLASMA DONATION. THE CENTER REPORTED THAT APPROXIMATELY 392ML OF PLASMA HAD BEEN COLLECTED PRIOR TO RECEIVING AN HB DETECT ALARM (CHECK FOR PLASMALINE HEMOGLOBIN (HB) FROM THE AUTO-C DEVICE. THE OPERATOR TEMPORARILY HALTED THE COLLECTION PROCEDURE AND IDENTIFIED THE PRESENCE OF A KINK IN THE CONCENTRATED CELL TUBING OF THE SET. THE OPERATOR WAS UNABLE TO RESOLVE THE KINK, THEREFORE THE PROCEDURE WAS TERMINEDATED. THE DONOR WAS DISCONNECTED WITHOUT THE RETURN OF THE RESERVOIR CONTENTS (APPROXIMATELY 63 ML OF RBC). THE DONOR WAS RELEASED IN APPARTENTLY GOOD CONDITION AND THE DISPOSABLE SET WAS DISCARDED BY CENTER. A FOLLOW-UP CALL BY THE CENTER TO THE DONOR VERIFIED THAT THE DONOR'S URINE HAD CLEARED, DONOR FELT FINE, AND DONOR HAD NOT SOUGHT ANY MEDICAL ATTENTION. THE DONOR WAS DEFERRED FOR ONE WEEK AT THE PLASMA CENTER FOLLOWING THIS EVENT. THE DONOR HAD SINCE RETURNED TO DONATE (X3 SINCE THIS REPORT) WITHOUT ANY DIFFICULTIES OR ADVERSE SYMPTOMS. A HISTORICAL REVIEW OF THE COMPLAINT REPORTING DATABASE WAS CONDUCTED FOR LOT A03G07015 AND NO SIMILAR REPORTS WERE FOUND. A BATCH REVIEW WAS COMPLETED FOR LOT A03G07015 AND ALL APPROPRIATE TESTING RESULTS WERE FOUND TO BE WITHIN SPECIFICATION REQUIREMENTS. THE STERILIZATION DOSE APPLIED TO THE FINISHED PRODUCT WAS APPROPRIATE FOR PRODUCT SPECIFICATION. THE MICROBIOLOGICAL TEST RESULT WAS SATISFACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PLASMACELL C DISPOSABLE SET SPIKESMART PLASMACELL-C DISPOSABLE SET GKT BAXTER HEALTHCARE CORP. NA A03G07015

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other SALINE, LOT C585224 (EXP DATE 10/04), 2003,| AUTOPHERESIS-C INSTRUMENT, 2003.| NEEDLE, LOT B03E03N1 (EXP DATE 05/06), 2003,| SODIUM CITRATE, LOT C584755 (EXP DATE 01/05),2003,