BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PCS2 PLASMA COLLECTION SYSTEM

    MDR report key: 10421265 · Received August 18, 2020

    Report

    Report Number
    1219343-2020-00073
    Event Type
    Injury
    Date Received
    August 18, 2020
    Date of Event
    July 26, 2020
    Report Date
    July 27, 2020
    Manufacturer
    HAEMONETICS COPORATION
    Product Code
    GKT
    PMA / PMN Number
    BK150292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    HAEMONETICS FIELD SERVICE ENGINEER (FSE) WENT ON-SITE TO ANALYZE THE PCS2 DEVICE AND CONCLUDED THAT THERE WAS NO FAULT AND FOUND THAT THE DEVICE WAS WITHIN SPECIFICATION. IN ADDITION, THE REVIEW OF THE DISPOSABLE PHOTOS PROVIDED BY THE CUSTOMER ALSO FOUND NO DEFECT. ALTHOUGH IT WAS STATED THAT THE DONOR HAD A FOLLOW UP APPOINTMENT WITH THE HOSPITAL NO ADDITIONAL INFORMATION OF THE VISIT OR VITAL SIGNS OR PREEXISTING CONDITIONS WHERE PROVIDED BY THE CUSTOMER. NO EVIDENCE FOR A SERIOUS INJURY HAS BEEN PROVIDED BY EITHER DONOR OR COLLECTION CENTER, BUT THE SYMPTOM OF FLANK PAIN AFTER A POTENTIAL EVENT OF HEMOLYSIS RAISES THEORETICAL CONCERNS ABOUT A POTENTIAL KIDNEY INVOLVEMENT. IN THE ABSENCE OF FURTHER INFORMATION, IT WAS DEEMED APPROPRIATE TO REPORT THE EVENT OUT OF AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    ON JULY 27, 2020 HAEMONETICS CORPORATION WAS INFORMED BY THE CUSTOMER TALECRIS PLASMA RESOURCES, THAT DURING PLASMAPHERESIS OF A DONOR ON (B)(6) 2020, THE PHLEBOTOMIST NOTICED THAT THE UNIT LOOKED RED, AS IF WITH RED BLOOD CELLS (RBC) DURING THE FIRST RETURN, AND SUSPECTED HEMOLYSIS OCCURRING WHILE USING THE PCS2 PLASMA COLLECTION SYSTEM. THE DONOR VITAL SIGNS WERE TAKEN TWICE, ONCE AT THE ONSET OF HEMOLYSIS EVENT AND ONCE RIGHT AFTER THE EVENT. THE CUSTOMER FOLLOWED THEIR LOCAL STANDARD OPERATING PROCEDURE (SOP) AND PROVIDED 100 ML OF SALINE INTRAVENOUSLY (IV). THEY CALLED EMS AND THE DONOR WAS THEN TAKEN TO THE HOSPITAL. AT THE HOSPITAL THE DONOR RECEIVED ADDITIONAL IV FLUID AND, AS STATED TO THE CUSTOMER, THE DONOR EXPERIENCED LOWER BACK AND FLANK PAIN THAT BEGAN ON (B)(6) 2020. THE DONOR SCHEDULED A FOLLOW UP APPOINTMENT WITH THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887062 PCS2 PLASMA COLLECTION SYSTEM PCS2, 06002-110-NA GKT HAEMONETICS COPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention