BEUDAMED
    FDA Adverse Event Other Summary report: N

    CLOSED APHERESIS KIT, FILTER, PL732, SAMPLE POUCH, AMS

    MDR report key: 166413 · Received May 6, 1998

    Report

    Report Number
    2314912-1998-00005
    Event Type
    Other
    Date Received
    May 6, 1998
    Date of Event
    February 11, 1997
    Report Date
    May 5, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    GKT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE BEGINING OF AN APHERSIS PROCEDURE THE NURSE NOTICED THAT THE APHERESIS DONOR HAD DEVELOPED SWELLING AT BOTH VENIPUNCTURE SITES. THE CONDITION PROGRESSED TO A RASH AND THEN TO A GENERALIZED FLUSHING OF THE DONOR'S BODY. THE APHERESIS PROCEDURE WAS IMMEDIATELY DISCONTINUED. NO MEDICATION OR OTHER MEDICAL INTERVENTION WAS REQUIRED. THE DONOR RECUPRATED. THIS DONOR HAD DONATED ON MANY PREVIOUS OCCASIONS. THIS EVENT WAS NOT REPORTED TO FDA UNTIL AFTER THIS INSPECTION AND IT WAS REPORTED AS AN ADVERSE EVENT/OTHER. A RAST TEST CONDUCTED ON A BLOOD SAMPLE COLLECTED FROM THE DONOR 2/11/1997 YIELED A POSITIVE RAST TEST RESULTED OF 4.9. A BLOOD SAMPLE COLLECTED FROM THE DONOR 2/11/1997 YIELDED A POSITIVE RAST TEST RESULT OF 4.9. A BLOOD SAMPLE COLLECTED FROM THIS SAME DONOR 2/25/1997 YIELDED A POSITVE RAST TEST RESULT OF 4.0. BOTH TEST RESULTS INDICATED THAT SIGNIFICANT LEVELS OF IGE SPECIFIC OF EHTYLENE OXIDE (ETO-HSA) WERE DETECTED. BAXTER, IN CONSULATATION WITH THE FENWAL DIV MEDICAL DIRECTOR, RECOMMENDED THAT ANY DONOR WITH A POSITIVE RAST TEST BE DEFERRED FROM FUTURE APHEREIS DONATIONS. THE CLINICAL SYMPTOMS DISPLAYED BY THIS APHERESIS DONOR, A HISTORY OF MULTIPLE APHERESIS DONATIONS AND THE POSITIVE DONOR RAST TEST MAY INDICATE DONOR HYPERSENSITIVITY. HYPERSENSITIVE DONORS MAY EXPEREINCE ADVERSE PHYSIOLOGICAL REACTIONS, INCLUDING ANAPYLACTIC SHOCK WHEN EXPOSED TO MEDICAL DEVICES STERILIZED WITH ETHYLENE OXIDE. DISCONTINUING AN APHERSIS PROCEDURE DUE TO THE OCCURRENCE OF ADVERSE PHYSIOLOGIC REACTION IS MEDICAL INTERVENTION. THIS EVENT SHOULD HAVE BEEN REPORTED TO THE FDA IN ACCORDANCE WITH THE PROVIDSIONS OF 21 CFR PART 803 AS A SERIOUS INJURY. YOU SHOULD SUBMIT AN MDR SUPPLMENTAL REPORT REGARDING THIS SERIOUS INJURY FOLLOWING THIS CORRESPONDENCE.

    Description of Event or Problem · 1

    ON 2/11/1997 AT THE ONSET OF AN APHERESIS PROCEDURE THE NURSE NOTICED THAT AT BOTH VENIPUNCTURE SITES THE DONOR HAD DEVELOPED SWELLING. THE CONDITION PROGRESSED TO A RASH AND THEN TO A GENERALIZED FLUSHING OF THE BODY. THE PROCEDURE WAS IMMEDIATELY DISCONTINUED. THE DONOR RECUPERATED OKAY. NO MED INTERVENTION OR MEDICATION WAS NECESSARY. THIS IS A FEMALE DONOR WHO HAD DONATED MANY TIMES BEFORE, THE NURSE REQUESTED TO HAVE THE DONOR TESTED FOR A POSSIBLE ETHYLENE OXIDE SENSITIVITY. THE CENTER SENT IN TWO BLOOD SAMPLES WHICH WERE REC'D BY FENWAL ON 2/25/97 & 2/26/97. RESULTS WERE 4.9 KU/L, AND 4.0 KU/L. THE CUSTOMER WAS NOTIFIED BY LETTER OF THESE RESULTS ON 3/12/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSED APHERESIS KIT, FILTER, PL732, SAMPLE POUCH, AMS CLOSED APHERESIS KIT, FILTER, PL732, SAMPLE POUCH, AMS GKT BAXTER HEALTHCARE CORP. NA H95L04012

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other