BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACP®215 AUTOMATED CELL PROCESSOR

    MDR report key: 5928900 · Received September 6, 2016

    Report

    Report Number
    1219343-2016-00060
    Event Type
    Injury
    Date Received
    September 6, 2016
    Date of Event
    July 28, 2016
    Report Date
    August 9, 2016
    Manufacturer
    HAEMONETICS CORP
    Product Code
    KSW
    PMA / PMN Number
    BK06008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A HAEMONETICS FIELD SERVICE ENGINEER (FSE) EVALUATED THE DEVICE. SEVERAL PROCEDURES WERE COMPLETED WITH NO ISSUES. THE FSE WAS NOT ABLE TO CONFIRM THE REPORTED DEFECT. THE DEVICE WAS PUT THROUGH DIAGNOSTIC TESTING AND ALL TESTS WERE WITHIN MANUFACTURER SPECIFICATIONS. THE EVALUATION OF THE BOWL HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SENT ONCE THE INVESTIGATION IS FINAL.

    Additional Manufacturer Narrative · 1

    THE BOWL THAT WAS USED IN THE REPORTED ISSUE WAS RETURNED FOR TESTING. THE BOWL PASSED SPIN TESTING THROUGH ALL CYCLES PER HAEMONETICS STANDARD PROCEDURES. WITH THE BOWL PROPERLY ALIGNED AND FULLY SEATED IN THE CENTRIFUGE CHUCK, THE BOWL FUNCTIONED AS INTENDED WITH NO FUNCTIONAL DEFECTS FOUND. THE BOWL HAD NO AUDIBLE NOISE AND MAINTAINED ITS INITIAL SEATING IN THE CENTRIFUGE CHUCK THROUGHOUT THE ENTIRE SIMULATED PROCEDURE. DIMENSIONS CRITICAL TO THE BOWL MAINTAINING SEATING IN THE CENTRIFUGE CHUCK WERE MEASURED TO SPECIFICATIONS AND THE BOWL BODY AND CENTER REGISTER WERE WITHIN TOLERANCE. THE VISUAL INSPECTION FOUND THE BOWL HAD HEAVY ABRASIONS ON THE SEAL CROWN AND HEADER SHIELD SKIRT. THE ABRASIONS INDICATE THAT THE BOWL WAS IMPROPERLY SEATED OR POORLY ALIGNED IN THE CENTRIFUGE, CAUSING THE HEADER SHIELD SKIRT TO COME IN CONTACT WITH THE SEAL CROWN. ABRASIONS OCCURRED BY THE BOWL SPINNING WHILE THE HEADER SHIELD SKIRT AND SEAL CROWN WERE IN CONTACT WITH EACH OTHER. ALTHOUGH ABRASIONS ON THE BOWL WERE FOUND, THE FUNCTIONAL TESTING COULD NOT REPLICATE THIS DEFECT AND THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    HAEMONETICS RECEIVED A REPORT STATING THAT ON (B)(6) 2016 DURING USE OF THE ACP5 AUTOMATED CELL PROCESSOR, THE OPERATOR EXPERIENCED A VERY NOISY BOWL DURING PROCESS. THE CUSTOMER STATES THE BOWL WAS APPARENTLY PROPERLY INSTALLED, NO LEAK, NO ALARM. THE USER WAS SENT TO ENT EMERGENCY SERVICE, WITH TINNITUS, PAIN, DEAFNESS. SYMPTOMS LASTED 9-12 HOURS. CORTICOID TREATMENT WAS PRESCRIBED. FOLLOWING THE INCIDENT, THE OPERATOR DEVELOPED A COLD RESULTING IN AN EAR INFECTION WHICH MADE THE INITIAL SYMPTOMS WORSE AND SLOWED THE RECOVERY PROCESS. AS OF (B)(6) 2016, THE OPERATOR HAD MADE A FULL RECOVERY WITH NO PERMANENT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581164 ACP®215 AUTOMATED CELL PROCESSOR ACP215 KSW HAEMONETICS CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention 0235P-00 LOT 8515052