BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTHREX ANGEL PRP KIT (US TRAY)

    MDR report key: 9607408 · Received January 20, 2020

    Report

    Report Number
    1220246-2020-01582
    Event Type
    Injury
    Date Received
    January 20, 2020
    Date of Event
    December 27, 2019
    Report Date
    April 22, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    ORG
    UDI-DI
    00888867279919
    PMA / PMN Number
    BK180180
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PER THE FOLLOWING: DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION CENTER FOR DEVICES AND RADIOLOGICAL HEALTH MEDICAL DEVICE REPORTING (B)(4) SUBJECT: REPORT NUMBER: 1220246-2020-01582 DEAR VIK BAJNATH, WE RECEIVED THE REPORT(S) REFERENCED ABOVE CONCERNING ONE OR MORE ADVERSE EVENTS INVOLVING YOUR DEVICE. TO COMPLETE OUR EVALUATION OF THE EVENT(S), WE REQUEST THE FOLLOWING INFORMATION. 1. MDR NUMBER REFERENCED ABOVE IDENTIFIES THE DEVICE AS THE ARTHREX ANGEL PRP KIT; HOWEVER, THE REPORT CITES BK110066 WHICH IS FOR A CONTAINER FOR COLLECTION AND PROCESSING OF BLOOD/BLOOD COMPONENTS. PLEASE CLARIFY WHAT DEVICE IS THE SUBJECT OF THIS MDR. THE FOLLOWING CHANGE HAS BEEN MADE TO THE SUPPLEMENTAL REPORT FOR 1220246-2020-01582: SECTION G4/G5 WILL SHOW A 510(K) OF BK180180.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PRP INJECTION, THE ABS-10061T, MALFUNCTIONED. THE CASSETTE PORTION OF THE KIT BROKE WHEN IT STARTED SPINNING AND THE BLOOD DRAINED INTO THE MACHINE. THE FACILITY ENDED UP LOSING ALL THE BLOOD THAT WAS DRAWN BUT THE SURGEON WANTED TO GO AHEAD AND TRY AGAIN WITH A SECOND KIT. THE SECOND KIT WAS SUCCESSFUL. ADDITIONAL INFORMATION REQUESTED ON 12/30/2019. ADDITIONAL INFORMATION RECEIVED 12/30/2019: IT WAS REPORTED THAT DURING AN ARTHROSCOPIC MENISCAL REPAIR WITH PRP INJECTION, THE ABS-10061T, MALFUNCTIONED. THE CASSETTE PORTION OF THE KIT BROKE WHEN IT STARTED SPINNING AND THE BLOOD DRAINED INTO THE MACHINE. THE FACILITY ENDED UP LOSING ALL THE BLOOD THAT WAS DRAWN BUT THE SURGEON WANTED TO GO AHEAD AND TRY AGAIN WITH A SECOND KIT WHICH WAS SUCCESSFUL. IT WAS FOUND THAT BLOOD SPLATTERED ONTO THE SURROUNDING WALLS AND AROUND THE CART THAT THE ANGEL MACHINE WAS SITTING ON. THE REP CLEANED THE WALLS, CART, AND SURROUNDING AREAS WITH TOWELS AND CLEANING SOLUTION. THE REP ALSO CLEANED THE BLOOD THAT WAS IN AND ON THE ANGEL MACHINE WITH TOWELS AND CLEANING SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68098 ARTHREX ANGEL PRP KIT (US TRAY) PLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING ORG ARTHREX, INC. ARTHREX ANGEL PRP KIT (US TRAY) 918495126 00888867279919

    Patients

    Seq Age Sex Outcome Treatment
    1 Other