BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALYX COMPONENT COLLECTION SYSTEM

    MDR report key: 2220206 · Received August 9, 2011

    Report

    Report Number
    3004548776-2011-00002
    Event Type
    Injury
    Date Received
    August 9, 2011
    Date of Event
    July 12, 2011
    Report Date
    July 13, 2011
    Manufacturer
    AVENDIA FENWAL
    Product Code
    GKT
    PMA / PMN Number
    BK080053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW OF THE SOLUTIONS USED WAS PERFORMED AND HASN'T SHOWN ANY EXCEPTION OR DEVIATION. THE KIT WAS EVALUATED, SAMPLE DOESN'T REVEAL ANY PARTS OR MFG ABNORMALITIES THAT WOULD CONTRIBUTE TO THE REPORTED INCIDENT. A MEDICAL ASSESSMENT WAS PERFORMED ON (B)(4): THE SYMPTOMS THAT THE DONOR DEVELOPED PLEAD FOR AN ALLERGIC OR AN ALLERGIC-LIKE REACTION. GIVEN THE SHORT LENGTH OF THE APHERESIS PROCEDURE BEFORE THE SYMPTOMS OCCURRED, THIS SEEMS HIGHLY UNLIKELY. ALLERGY CAN BE DIRECTED TOWARDS A PRODUCT ADMINISTERED DURING THE PROCEDURE, OR TO ANOTHER ALLERGEN TO WHICH THE PT IS EXPOSED ENVIRONMENTALLY DURING THE APHERESIS PROCEDURE. ALLERGY TO THE SOLUTIONS USED DURING THE PROCEDURE; ACETATE, CITRATE AND DEXTROSE IS VERY UNLIKELY. THE FACT THAT A MEMBER OF THE MEDICAL TEAM HAS EXPERIENCED SIMILAR SYMPTOMS, ALTHOUGH MORE BENIGN, ON THE SAME DAY, AND THE FACT THAT THE ROOM HAD BEEN PAINTED 48H BEFORE THE INCIDENT PLEADS ALSO FOR A POSSIBLE ALLERGY TOWARDS ONE OF THE COMPONENTS THAT HAS BEEN USED BY THE PAINTERS. (B)(4).

    Description of Event or Problem · 1

    THE REGULAR APHERESIS DONOR STARTED AT 10 MIN FROM THE DOUBLE RED CELL COLLECTION, A CRISIS OF SNEEZING WITH WATERY RHINORRHEA AND NASAL CONGESTION, NO COMPLAINTS OF COUGH, PARESTHESIA OF THE THROAT / LARYNX OR DYSPNOEA. THE SYMPTOMS REPORTED KEEP ON AND AT THE END OF THE PROCEDURE, COMES BILATERAL CONJUNCTIVAL INJECTION WITHOUT ITCHING OR TEARING AND WITHOUT DYSPNOEA, COUGH OR PARESTHESIAS OF THE LARYNX. AFTER THE TERMINATION OF THE PROCEDURE BUT STILL IN A SUPINE POSITION, THERE IS PERI-ORBITAL EDEMA AND BILATERAL EYELID AND ORTHOPNEA. IN A SITTING POSITION, IT COMES TO A RESPIRATORY FAILURE AND ACUTE (5 MIN AFTER THE CESSATION OF APHERESIS), DYSPNEA, RETRACTIONS, INCREASED EXPIRATORY TIME AND THEN FEELING OF SUFFOCATION. CP AUSCULTATION REVEALED WHEEZING BILATERALLY. TEN MIN AFTER THE ONSET OF RESPIRATORY SYMPTOMS, HE MAKES TWO INHALATIONS OF SALBUTAMOL AND 100 MG HYDROCORTISONE IS ADMINISTERED INTRAVENOUSLY, CLEMASTINE 2 MG IV AND A FORMULA O2 31/MN HAVING RELIEVED THE SYMPTOMS BUT NOT COMPLETELY. SO IN AN IMPROVED STATE AND NOW WITHOUT DYSPNOEA, HE IS SENT IN THE (B)(6) AMBULANCE TO THE HOSPITAL (B)(6) ACCOMPANIED BY A LETTER OF REFERENCE. DONOR WAS RELEASED 3 HOURS LATER, AFTER CONDUCTING RESPIRATORY GAS MEASUREMENT, WHICH REVEALED NO ALTERATIONS AND TREATED WITH PREDNISOLONE 5MG (1 COMP. 3 TIMES DAILY FOR 3 DAYS) AND DESLORATADINE (1 COMP. / DAY FOR 3 DAYS). FURTHERMORE, IT WAS SUGGESTED THE DONOR UNDERGO ALLERGY TESTING. THE FOLLOWING DAY, DONOR WAS CONTACTED BY THE DOCTOR OF (B)(6) WHICH SHOWED THAT THE DONOR IS ASYMPTOMATIC, EXCEPT A SLIGHT EDEMA PALPEBRAL AND IS INSTRUCTED TO KEEP ON THE MEDICATION. THE DECISION NOT TO DISCONTINUE THE PROCEDURE AT THE ONSET OF NASAL SYMPTOMS, WAS RELATED TO THE FACT THAT THE DONOR HAS A HISTORY OF ASTHMA (THOUGH NO RECORD OF CRISIS FOR SEVERAL YEARS WITHOUT MAINTENANCE THERAPY INSTITUTED). THE DONOR ROOM HAD BEEN PAINTED 48 HOURS PRIOR TO DONATION AND THE MEDICAL TEAM PRESENT DURING THE DONATION EXPRESSED THE SAME SYMPTOMS AND TOOK A NASAL ANTIHISTAMINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALYX COMPONENT COLLECTION SYSTEM BLOOD CELL SEPARATOR KIT GKT AVENDIA FENWAL NA FN11C29018

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention