BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCS2

    MDR report key: 2220034 · Received August 9, 2011

    Report

    Report Number
    1219343-2011-00118
    Event Type
    Malfunction
    Date Received
    August 9, 2011
    Date of Event
    June 23, 2011
    Report Date
    August 5, 2011
    Manufacturer
    HAEMONETICS CORP.
    Product Code
    GKT
    PMA / PMN Number
    BK040025
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(4) 2011 AND ALLEGED THAT BLOOD WAS MIGRATING UP THE ANTICOAGULANT LINE ON THE PLASMA COLLECTION SYSTEM DURING THE RETURN PHASE. IT IS UNK WHICH CYCLE THIS OCCURRED. NO DONOR INJURY OR REACTION REPORTED. NO OPERATOR INJURY REPORTED. THE DEVICE COMPONENT WAS RETURNED ON (B)(4) 2011 AND EVALUATED. THE PUMP ROTORS WERE FOUND TO BE WORN AND UNABLE TO PROPERLY OCCLUDE THE PUMP TUBING. THE WORN ROTOR HAS BEEN REPLACED. THE MACHINE IS NOW WITHIN PERFORMANCE SPECS AND HAS HAD NO FURTHER INCIDENTS. AS REPORTED, BLOOD MIGRATING TO THE ANTICOAGULANT (AC) LINE COULD ONLY LEAD TO AN INSIGNIFICANT RBC LOSS DURING THE LAST RETURN ONLY AND WOULD NOT RESULT IN A SERIOUS INJURY. THE MALFUNCTION AS NOTED WOULD RESULT IN A DECREASE IN PUMP EFFICIENCY. AS A RESULT, THIS COULD ALLOW AN INCREMENTAL EXCESS FLOW OF AC INTO THE SYSTEM DURING DRAW AND WHEN PUMPS ARE STOPPED. AS A RESULT, A MORE THAN TYPICAL AMOUNT OF AC COULD BE ADMINISTERED TO THE DONOR. EXCESS ANTICOAGULANT DELIVERED TO THE DONOR POSES A POTENTIAL SERIOUS INJURY. SYMPTOMS OF EXCESS AC DELIVERY RANGE FROM NO REACTION TO ACUTE. NO INJURY OR REACTION REPORTED AS A RESULT OF THIS MALFUNCTION.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED HAEMONETICS ON (B)(6) 2011 AND ALLEGED THAT BLOOD WAS MIGRATING UP THE ANTICOAGULANT LINE ON THE PLASMA COLLECTION SYSTEM DURING THE RETURN PHASE. IT IS UNK WHICH CYCLE THIS OCCURRED. NO DONOR INJURY OR REACTION REPORTED. NO OPERATOR INJURY REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NI