BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PCS®2 PLASMA COLLECTION SYSTEM

    MDR report key: 7881317 · Received September 17, 2018

    Report

    Report Number
    1219343-2018-00034
    Event Type
    Malfunction
    Date Received
    September 17, 2018
    Date of Event
    August 19, 2018
    Report Date
    September 17, 2018
    Manufacturer
    HAEMONETICS CORPORATION
    Product Code
    GKT
    PMA / PMN Number
    BK920039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2018, HAEMONETICS WAS MADE AWARE OF AN AC DEPLETION INCIDENT INVOLVING A PCS2 DEVICE AT A CSL PLASMA DONATION CENTER. CSL PLASMA INDICATED THAT THE PUMP ROTORS WERE ACCIDENTALLY REVERSED BY THE ON-SITE TECHNICIAN FOLLOWING A MONTHLY MAINTENANCE AND CLEANING ACTIVITY, THE REVERSAL OF THE PUMP ROTORS THEN RESULTED IN THE END-USER INSTALLING THE COLLECTION SET ONTO THE DEVICE IN AN INCORRECT ORIENTATION WHICH. THIS INCORRECT SETUP OF THE DISPOSABLE COLLECTION SET RESULTED IN EXCESSIVE AMOUNTS OF ANTICOAGULANT (AC) BEING DRAWN INTO THE COLLECTION SET, AS THE AC LINES WERE INSTALLED INTO THE SALINE PUMP, AND THE SALINE LINES WERE INSTALLED INTO THE AC PUMP. HAEMONETICS HAS SENT REPLACEMENT PUMP ROTORS TO BE INSTALLED BY CSL PLASMA'S ON-SITE TECHNICIAN. CSL PLASMA HAS REPORTED THAT THE PCS2 DEVICE HAS BEEN REMOVED FROM SERVICE PENDING THE REPLACEMENT ROTORS, ONCE THE ROTORS HAVE BEEN RECEIVED THE ON-SITE TECHNICIAN WILL PERFORM THE INSTALLATION AND CALIBRATE THE DEVICE PRIOR TO RETURNING IT TO SERVICE. THE DONOR DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS OF A CITRATE REACTION, AS A RESULT NO MEDICAL INTERVENTION WAS REQUIRED TO PREVENT ANY INJURY. EVEN THOUGH THERE WAS NO INJURY OR ADVERSE REACTION EXPERIENCED BY THE DONOR, HAEMONETICS HAS PREVIOUSLY REPORTED INSTANCES OF ANTICOAGULANT DEPLETION WHICH RESULTED IN DONORS EXPERIENCING AN ADVERSE CITRATE REACTION.

    Description of Event or Problem · 1

    ON (B)(6) 2018, HAEMONETICS RECEIVED A NOTIFICATION OF A PLASMA DONATION PROCEDURE IN WHICH AN ANTICOAGULANT DEPLETION WAS OBSERVED. THE CSL PLASMA REPORTED THAT THE ENTIRE 250ML BAG OF ANTICOAGULANT SOLUTION WAS DISPENSED INTO THE COLLECTION SET DURING A PLASMA COLLECTION PROCEDURE. THE DONOR DID NOT EXPERIENCE ANY SIGNS OR SYMPTOMS OF A CITRATE REACTION, NO MEDICAL INTERVENTION WAS REQUIRED AND THE DONOR LEFT THE CENTER IN GOOD HEALTH. CSL PLASMA HAS NOTIFIED HAEMONETICS THAT THEY HAVE TAKEN THE PCS2 DEVICE OUT OF SERVICE UNTIL REPLACEMENT PUMP ROTOR ASSEMBLIES ARRIVE TO BE INSTALLED BY THE ON-SITE TECHNICIAN. CSL PLASMA NOTIFIED HAEMONETICS THAT THE AC PUMP ROTORS AND BLOOD PUMP ROTORS WERE MISTAKENLY REVERSED BY AN ON-SITE TECHNICIAN FOLLOWING A ROUTINE MONTHLY CLEANING AND MAINTENANCE ACTIVITY, WHICH RESULTED IN THE DISPOSABLE SET BEING LOADED IMPROPERLY AND CAUSING THE AC SOLUTION BAG TO BE DEPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723333 PCS®2 PLASMA COLLECTION SYSTEM SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC GKT HAEMONETICS CORPORATION 06002-110-NA

    Patients

    Seq Age Sex Outcome Treatment
    1