BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCS2

    MDR report key: 2201673 · Received August 4, 2011

    Report

    Report Number
    1219343-2011-00106
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 2, 2011
    Report Date
    August 1, 2011
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    CAC
    PMA / PMN Number
    B040025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BOTTLE UNIT WAS RETURNED ON (B)(6), 2011. THE ALCOHOL SMELL WAS CONFIRMED. RETAINED FLUID WAS OBSERVED IN THE BOTTLE AND A SAMPLE WAS SENT TO A LAB FOR EVAL. THE LAB CONFIRMED THAT THE SAMPLE APPEARS TO BE ISOPROPYL ALCOHOL WITH WATER ADDED VIA FTIR. THE INVESTIGATION IS ONGOING. A F/U REPORT WILL BE FILED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6), 2011 AND ALLEGED THAT UPON REMOVING A BOTTLE FROM THE PACKAGING, A STRONG ODOR OF ALCOHOL WAS PRESENT ON THE PCS2 PLASMA COLLECTION SYSTEM. NO OPERATOR INJURY REPORTED. NO DONOR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCS2 PLASMA COLLECTION SYSTEM CAC HAEMONETICS CORP. NA 1105504B

    Patients

    Seq Age Sex Outcome Treatment
    1 NA