BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHOENIX

    MDR report key: 3242775 · Received July 23, 2013

    Report

    Report Number
    9616240-2013-00003
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 15, 2013
    Report Date
    July 3, 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

    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 DASCO REQUESTED THE PHOENIX MACHINE TO BE INSPECTED BY A GAMBRO TECHNICIAN BUT THE CUSTOMER DID NOT WANT TO PULL IT FOR SERVICE. GAMBRO HAS NO INFORMATION TO SUGGEST THAT ANY GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE INCIDENT AND GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    WITHIN MINUTES OF INITIATING A DIALYSIS TREATMENT THE PATIENT BECAME RESTLESS AND CODED. THE BLOOD FROM THE EXTRACORPOREAL CIRCUIT WAS RETURNED TO THE PATIENT AND TREATMENT ENDED. THE PATIENT WAS TREATED FOR AN ACUTE ALLERGIC REACTION AND SUCCESSFULLY RESUSCITATED WITHIN SEVERAL MINUTES. EARLIER IN THE DAY, THE PATIENT HAD A SIMILAR REACTION WITHIN MINUTES OF INITIATING THE DIALYSIS TREATMENT. (REFERENCE MDR MFR 9616240-2013-00002) THE RENAL SERVICES NURSE MANAGER STATED AFTER THE SECOND TREATMENT, IT WAS THE OPINION OF THE PHYSICIAN THAT THE PATIENT HAD EXPERIENCED AN ALLERGIC REACTION TO THE DIALYZER DURING BOTH TREATMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342665 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