BEUDAMED
    FDA Adverse Event Summary report: N

    MCB 214-100 BICARB SYSTEM

    MDR report key: 5059342 · Received September 5, 2015

    Report

    Report Number
    3019131-2015-00003
    Date Received
    September 5, 2015
    Date of Event
    August 7, 2015
    Report Date
    September 4, 2015
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIN
    PMA / PMN Number
    K003560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED INITIAL REPORT FROM CLINIC ON 8.7.2015. MULTIPLE CONTACT ATTEMPTS HAVE BEEN MADE ALONG WITH MESSAGES LEFT FOR DR. (B)(6) OVER THE LAST 30 DAYS REQUESTING ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN FORTHCOMING.

    Description of Event or Problem · 1

    CLINIC CALLED TO REPORT THAT WHILE PERFORMING A BLEACH DISINFECT OF THEIR MCP SYSTEM (HEMODIALYSIS DIALYSATE BICARBONATE MIXER), THE STAFF INADVERTENTLY SENT THE MIXTURE TO THE PATIENT FLOOR. POTENTIAL OF AFFECTING 20 PATIENTS. CLINIC WAS MONITORING HEMO LEVELS AND DID NOT REPORT ANY ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590335 MCB 214-100 BICARB SYSTEM TANK, HOLDING DIALYSIS FIN MAR COR PURIFICATION 214-100

    Patients

    Seq Age Sex Outcome Treatment
    1 Other