BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLEX PHOTOPHERESIS SYSTEM

    MDR report key: 15871712 · Received November 28, 2022

    Report

    Report Number
    3013428851-2022-00080
    Event Type
    Malfunction
    Date Received
    November 28, 2022
    Date of Event
    November 1, 2022
    Report Date
    January 31, 2023
    Manufacturer
    MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED
    Product Code
    LNR
    PMA / PMN Number
    P860003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHOTOGRAPHS AND THE SMART CARD WERE PROVIDED BY THE CUSTOMER FOR EVALUATION. THE COMPLAINT KIT WAS NOT RETURNED. A REVIEW OF THE DATA RECORDED ON THE RETURNED SMART CARD VERIFIED THE TREATMENT WAS ABORTED AFTER 1547 ML OF WHOLE BLOOD HAD BEEN PROCESSED. REVIEW OF THE PROVIDED PHOTOGRAPHS VERIFIED THAT THE RECIRCULATION PUMP LOOP TUBING IS NO LONGER ATTACHED TO THE PORT OF THE T-CONNECTOR. A DEVICE HISTORY RECORD (DHR) REVIEW DID NOT RESULT IN ANY RELATED NON-CONFORMANCES. THIS LOT PASSED ALL LOT RELEASE TESTING. THE TUBING DETACHING FROM THE BOND PORT INDICATES THE SOLVENT BOND JOINT WAS WEAK. THE ROOT CAUSE FOR THE TUBING LEAK IS MOST LIKELY DUE TO MANUFACTURING OPERATOR ERROR DURING THE TUBE BONDING OPERATION. RETRAINING HAS BEEN COMPLETED WITH ALL BONDING OPERATORS. NO FURTHER ACTION IS REQUIRED AT THIS TIME. THIS INVESTIGATION IS NOW COMPLETE. (B)(4). 31-JAN-2023.

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WERE NOT PROVIDED. THE COMPLAINED BCD VANGUARD IS A NON STERILE COMPONENT SOLD TO AN ASSEMBLER IN JAPAN. THE EXPIRATION DATE OF THE STERILE COMPONENEN IS UNKNOWN. THE COMPLAINED BCD VANGUARD (CATALOG NUMBER 050228J IS NOT DISTRIBUTED IN THE USA, THEREFORE THE UDI IS NOT APPLICABLE. THE PRODUCT ITEM 050228J IS NOT DISTRIBUTED IN THE USA, BUT IT IS SIMILAR TO THE BCD VANGUARD ITEM 050228, WHICH IS DISTRIBUTED IN THE USA (510(K) NUMBER: K934847). THE COMPLAINED BCD VANGUARD IS A NON STERILE COMPONENT SOLD TO AN ASSEMBLER IN JAPAN. THE MANUFACTURING DATE OF THE STERILE DEVICE IS UNKNOWN. SORIN GROUP ITALIA MANUFACTURES THE BCD VANGUARD. THE INCIDENT OCCURRED IN JAPAN. FOLLOW UP WITH THE CUSTOMER CLARIFIED THAT: - WHEN THE EVENT OCCURRED, THE UNIT WAS FILLED WITH BLOOD, AND THE THREE-WAY STOPCOCK WAS NOT OPENED. THE CUSTOMER THINKS THAT THE EVENT WOULD NOT OCCUR DUE TO A POSITIONAL DROP. - THE UNIT WAS TESTED BY THE JAPANESE ASSEMBLER AND WATER IN THE CIRCUIT LEAKED OUT. ACCORIND TO SUBSEQUENT CLARIFICATION, AFTER THE FILLING OF THE UNIT, CLAMP ON INLET PORT WAS RELEASED AND THE LEVEL OF FLUID INSIDE THE UNIT DECREASED DUE TO AIR INTAKE FROM TOP AREA. IF ANY ADDITIONAL INFORMATION PERTINENT TO THE REPORTED EVENT IS RECEIVED, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM 360 INFUSION PUMP. THE CUSTOMER REPORTED THAT THE PUMP WAS ACTIVELY DELIVERING MEDICATION. THE NURSE CHECKED ON THE PUMP AND FOUND THAT THE SCREEN SAID, ¿NEW PATIENT?¿¿. THE NURSE SELECTED ¿NO¿, AND THE PUMP SHUT DOWN. THE UNIT DID NOT ALARM, AND IT WAS OPERATING IN AC MODE. IT IS NOT KNOWN HOW LONG THE PUMP HAD BEEN INFUSING OR WHAT MEDICATIONS WERE BEING INFUSED. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1671853 CELLEX PHOTOPHERESIS SYSTEM CELLEX PHOTOPHERESIS SYSTEM LNR MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED NA L322

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female