BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSED APHERESIS KIT, PL3014, SAMPLE POUCH, AMS

    MDR report key: 166399 · Received May 6, 1998

    Report

    Report Number
    2314912-1998-00007
    Event Type
    Injury
    Date Received
    May 6, 1998
    Date of Event
    September 19, 1996
    Report Date
    May 6, 1998
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    GKT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING AN APHERESIS PROCEDURE THE DONOR STARTED COUGHING, HD A FLUSHED FACE AND EXHIBITED HIVES ALL OVER THE BODY. THE DONOR WAS TAKN TO EMERGENY ROOM AND GIVEN ORAL BENADRYL AND RELEASED IN GOOD CONDITION. THIS DONOR HAD DONATED 162 TIMES. DONOR HAD A POSITIVE RAST TEST OF 12.4. A RAST TEST RESULT OF LESS THAN 2 INDICATES THAT NO SIGNIFICANT LEVELS OF IGE SPECIFIC FOR ETO-HSA WERE DETECTED. A RAST TEST RESULT GREATER THAN 2 INDICATES A POSITIVE TEST RESULT OR THAT SIGNIFICANT LEVELS OF IGE SPECIFIC FOR ETO-HSA WERE DETECTED. THIS EVENT WAS NOT REPORTED TO FDA UNTIL AFTER INSPECTION. BAXTER'S EVAL OF THIS COMPLAINT INDICATED THAT THERE HAD NEVER BEEN DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS TYPE OF MEDICAL DEVICE MALFUNCTION AND THE CHANCE OF DEATH OR SERIOUS INJURY RESULTING FROM THIS TYPE OF MEDICAL DEVICE WAS REMOTE. BAXTER, IN CONSULATATION WITH THE FENWALL MEDICAL DIRECTOR, RECOMMENDED THAT ANY APHERESIS DONOR WITH A POSITIVE RAST TEST BE DEFERRED FROM FUTURE APHERESIS DONATIONS. IN PUBLICATION, L. MUYLLE ET. AL. (L. MUYLLE ET AL.; ANAPHYLACTOID REACTION IN PLATELET-PHERESIS DONOR WITH IGE ANTIBODIES TO ETHYLENE OXIDE; THE LANCET, 11/22/1986, P. 1225, DESCRIBES THE OCCURENCE OF AN ANAPHYLACTOID REACTION 6 MINUTES AFTE THE START OF APHERESIS PROCEDURE. THE APHERESIS PROCEDURE WAS IMMEDIATELY STOPPED. THE DONOR WAS ADVISED AGAINST FUTURE DONATIONS. A RAST TEST RESULT OF 57 DEMONSTRATED. IN THE CASE DESCRIBED IN THE ENCLOSED PUBLICATION, THE SENSITIZATION OF THE INDIVIDUAL TO ETHYLENE OXIDE (ETO) FOLLOWED THE USE OF ETHYLENE OXIDE STERILZED MATERIAL. INDIVIDUALS THAT HAVE DONATED MULTIPLE TIMES, THAT EXHIBIT SYMPTOMS NOTED THIS THIS PARTICUALR CUSTOMER COMPLAINT, AND WHO ALSO HAVE A POSTIVIE RAST TEST MAY EXPERIENCE ADVERSE CLINICAL REACTION FOLLOWING EXPOSURE TO MEDICAL DEVICES STERILIZED WITH ETHYLENE OXIDE (ETO). IN THIS PARTICULAR CUSTOMER COMPLAINT, THE ADMINISTRATION OF BENADRYL WOULD CONSTITUTE MEDICAL INTERVENTION, THEREFORE, THIS EVENT SHOULD HAVE BEEN REPORTED TO FDA IN ACCORDANCE WITH THE PROVISIONS OF 21 CFR PART 803 AS A SERIOUS INJURY. SINCE YOUR FIRM SUBMITTED THIS EVENT FOLLOWING THE INSPECTION AS AN "ADVERSE REACTION / OTHER", YOUE MAY WISH TO SUBMIT A SUPPLEMENTAL REPORT IDENTIFYING THIS EVENT AS A SERIOUS INJURY.

    Description of Event or Problem · 1

    FENWAL'S CLINICAL EDUC DEPT REC'D INFO ON 9/19/96 THAT A DONOR HAD EXPERIENCED WHAT WAS BELIEVED TO BE AN ETHYLENE OXIDE RELATED REACTION. THE DONOR STARTED COUGHING, HAD A FLUSHED FACE AND EXHIBITED HIVES ALL OVER HIS BODY. THE DONOR WAS TAKEN TO THE ER. ON 9/19/96 FENWAL CUSTOMER QA CONTACTED SOURCE AT THE SUBJECT ACCOUNT TO OBTAIN FOLLOW UP INFO. SOURCE STATED THAT THE DONOR HAD BEEN GIVEN BENADRYL ORALLY IN THE ER AND RELEASED IN GOOD CONDITION. THE DONOR WAS SAID TO HAVE VISITED THE DONOR CTR LATER ON THAT AFTERNOON AND HE WAS IN GOOD CONDITION. CQA OFFERED TO HAVE THE DONOR TESTED FOR ETHYLENE OXIDE SENSITIVITY. THE TEST BLOOD SAMPLE WAS REC'D ON 10/1/1996. THE CUSTOMER WAS NOTIFIED OF THE POSITIVE RESULTS (12.4 KU/L) BY LETTER ON 10/15/1996.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLOSED APHERESIS KIT, PL3014, SAMPLE POUCH, AMS CLOSED APHERESIS KIT, PL3014, SAMPLE POUCH, AMS GKT BAXTER HEALTHCARE CORP. NA H96C13010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other