BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 3158198 · Received June 6, 2013

    Report

    Report Number
    1713747-2013-00174
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 13, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DURING F/U REVIEW BY THE POST-MARKET CLINICAL DEPARTMENT STAFF AND THE POST MARKET CLINICAL MEDICAL DIRECTOR DOCTOR TO DOCTOR REPORT IT WAS DISCOVERED THAT THE TREATING PHYSICIAN BELIEVED THAT THE SYMPTOMS THE PT WAS EXPERIENCING DURING DIALYSIS (NAUSEA, HEADACHE, HYPERTENSION), WHICH RESOLVED AFTER CHANGING DIALYZERS, WERE DUE TO A FRESENIUS DIALYZER REACTION. ALTHOUGH MEDICAL RECORDS WERE NOT RELEASE TO US AFTER SEVERAL REQUESTS, THE ATTENDING DOCTOR CANNOT RECALL THE ANTIHYPERTENSIVE MEDICINES THIS PT MAY HAVE BEEN TAKEN. CERTAIN ANTIHYPERTENSIVE MEDICINES MAY EXACERBATE HEADACHE AND NAUSEA DURING DIALYSIS. IN ADDITION, THIS PT WAS NOT RE-CHALLENGED TO CONFIRM A DIALYZER REACTION. DIALYZER REACTIONS ARE NOT BELIEVED TO BE A DEVICE MALFUNCTION, BUT AN IDIOSYNCRATIC REACTION RESULTING FROM THE GENETIC PT'S MAKE-UP, AND THE BLOOD INTERACTION WITH THE DIALYSIS MEMBRANE. IN THE COMPLAINANT'S OPINION, THE PT'S DOCTOR, THE SYMPTOMS WERE CONSISTENT WITH A REACTION TO THE DIALYZER AS THEY RESOLVED WHEN THE DIALYZER WAS CHANGED. A MDR REPORT WILL BE FILED ON THIS EVENT AS SERIOUS INJURY W/O MALFUNCTION. IN ADDITION, THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG PROCESS. THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    CUSTOMER SERVICE REC'D CALL FROM COMPLAINANT WHO SAID THAT A PT HAD NAUSEA, VOMITING AND HEADACHE 1 HR INTO TREATMENT WITH BLOOD PRESSURE OF 210/115. A BAXTER DIALYZER WAS USED FOR NEXT TREATMENT AND THE PT DID NOT DEVELOP THE SAME SYMPTOMS. F/U FROM POST MARKET CLINICAL SPECIALIST REVEAL THAT THE PT WAS ALREADY HYPERTENSIVE PRIOR TO THE START OF TREATMENT, AND THAT THE PT WAS FINE AFTER THE TREATMENT AND THE ONLY MEDICAL INTERVENTION REQUIRED WAS CHANGING THE DIALYZER PRESCRIPTION. THE MEDICAL RECORD WERE REQUESTED BUT THAT THEY WOULD NOT BE FURNISHED PER THE MANAGER AND THE RISK MANAGER DIRECTIVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249637 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. FJI FRESENIUS MEDICAL CARE NORTH AMERICA 13BU01006

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention