BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALOG A + HE/BIC

    MDR report key: 4001293 · Received July 24, 2014

    Report

    Report Number
    3002879653-2014-00248
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 25, 2014
    Manufacturer
    B. BRAUN AVITUM AG
    Product Code
    KDI
    PMA / PMN Number
    K083460
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). B BRAUN MEDICAL INC (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B BRAUN (B)(4) (MFR). THIS REPORT HAS BEEN IDENTIFIED AS B BRAUN (B)(4). THE INVESTIGATION OF THE DIALYSIS UNIT IS ONGOING AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION BECOME AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: APPROX 1/2 HOUR INTO TREATMENT THE PATIENT WAS REMOVED FROM THE MACHINE AND WAS TAKEN TO THE EMERGENCY ROOM FOR TREATMENT FOR POSSIBLE HEMOLYSIS. NO ADDITIONAL INFO IS AVAILABLE AT THIS TIME. THE CUSTOMER STATED THAT THEY USE THE SL2010M2096 STREAMLINES AND THAT THEY DO HAVE THE BLOOD LINES THAT WERE USED FOR THIS TREATMENT. ADDITIONAL INFO BY CUSTOMER RECEIVED: "I DON'T THINK IT WAS A HEMOLYSIS ISSUE, THE PATIENT ENDED UP HAVING A RT. PLEURAL EFFUSION AND SEVER PULMONARY EDEMA. THEY HAD A THORACENTESIS THAT DRAIN 900 ML OF FLUID AND NEED A NEW PERM CATH. THERE ARE MANY ISSUES WITH THIS PATIENT AND MY NURSES WERE JUST FOLLOWING PROTOCOL FOR A PATIENT THAT HAS ABRUPT SOB." ADDITIONAL INFO BY CUSTOMER RECEIVED: "THERE WAS NO BLOOD ALARM BECAUSE BLOOD NEVER CROSSED THE BARRIER. THERE WERE NO DISCREPANCIES WITH THE MACHINE. IF I KNEW THE NURSE DOING THE TREATMENT THAT DAY HEMOLYSIS WOULD NOT HAVE BEEN MY FIRST GO TO PROBLEM. BUT THEY KNEW THAT ABOUT ABRUPT SOB WAS ONE OF THE SYMPTOMS OF HEMOLYSIS AND DIDN'T LOOK AT OTHER REASONS SUCH AS A PE, MI, AND WHAT HE DID HAVE SEVER CHF AND A PLEURAL EFFUSION. SO SOME OF THIS MIGHT HAVE BEEN SOME INEXPERIENCE ON THE NURSE. EITHER WAY THE PATIENT IS FINE AND THE MACHINE IS BEING USED AGAIN NOW WITHOUT PROBLEMS. I DIDN'T KNOW THEY HAD SENT A REPORT THAT STATED HEMOLYSIS WAS A POSSIBLE CAUSE, OTHERWISE I WOULD HAVE SAID SOMETHING TO THEM. THE MACHINE WAS PULLED INSTANTLY AND REPLACED PER OUR PROTOCOL. WENT BACK INTO SERVICE AFTER BIOMED CHECKED IT OUT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432842 DIALOG A + HE/BIC HEMODIALYSIS SYSTEM KDI B. BRAUN AVITUM AG NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization SL2010M2096 STREAMLINES BLOOD LINE SET| SL2010M2096 STREAMLINES BLOOD LINE SET