BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX

    MDR report key: 3232755 · Received July 18, 2013

    Report

    Report Number
    9616240-2013-00002
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 15, 2013
    Report Date
    June 18, 2013
    Manufacturer
    GAMBRO DASCO S.P.A
    Product Code
    KDI
    PMA / PMN Number
    K070643
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: HEMODIALYSIS EQUIPMENT. THERE WERE NO REPORTED PROBLEMS WITH THE PHOENIX MACHINE ASSOCIATED WITH THIS EVENT. THE MACHINE HAS BEEN IN USE WITH NO PROBLEMS SINCE THE EVENT. GAMBRO (B)(4) REQUESTED THE PHOENIX MACHINE TO BE INSPECTED BY A GAMBRO TECHNICIAN BUT THE CUSTOMER DID NOT WANT TO PULL IT FOR SERVICE.

    Description of Event or Problem · 1

    A PATIENT WAS ADMITTED TO THE ICU AFTER EVALUATION IN THE ER FOR LETHARGY, HYPERTENSION AND HYPERKALEMIA. THE PATIENT HAS A HISTORY OF CHRONIC RENAL FAILURE AND CHRONIC DIALYSIS BUT WAS UNKNOWN TO THE FACILITY AND NEPHROLOGY GROUP. UPON ADMISSION TO THE ICU, THE PHYSICIAN ORDERED A DIALYSIS TREATMENT FOR THE PATIENT. WITHIN THE FIRST FEW MINUTES OF THE DIALYSIS TREATMENT, THE PATIENT BECAME RESTLESS, SAT UP IN BED SCREAMING, HAD AN INCREASE IN BLOOD PRESSURE, EXPERIENCED A SEIZURE AND CODED. THESE SYMPTOMS ARE CONSISTENT WITH A TYPE A DIALYZER REACTION WHICH IS AN ALLERGIC REACTION TO THE DIALYZER. THERE HAD BEEN NO PROBLEMS OR MACHINE ALARMS DURING THE TREATMENT. THE BLOOD FROM THE EXTRACORPOREAL CIRCUIT WAS RETURNED TO THE PATIENT AND TREATMENT ENDED. THE PATIENT WAS SUCCESSFULLY RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333567 PHOENIX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO DASCO S.P.A PHOENIX N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention CARTRIDGE BLOOD TUBING SET, REVACLEAR, BICART