BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENIUM 150 SYNTH HF DIALYZERSYNTHETIC FOR HEMODIALYSIS

    MDR report key: 2020383 · Received March 16, 2011

    Report

    Report Number
    1423500-2011-03268
    Event Type
    Injury
    Date Received
    March 16, 2011
    Date of Event
    February 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    NIPRO CORPORATION USD
    Product Code
    KDI
    PMA / PMN Number
    K062079
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ADDITIONAL CLINICAL INFORMATION RECEIVED HAS BEEN REVIEWED IN DETAIL AND IT HAS BEEN DETERMINED THAT THE PATIENT'S CONDITIONS WERE NOT RELATED TO THE DIALYZER.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. THIS IS REPORT 7 OF 7 FOR THIS EVENT.

    Description of Event or Problem · 1

    ON 03/11/2011, A FACILITY MANAGER REPORTED THAT A PATIENT IS HAVING A LOT OF PROBLEMS WITH ALL THE DIALYZERS AND THEY ARE USING THIS EXELTRA 150 DIALYZER DUE TO POSSIBLE ALLERGY WITH THE OTHER DIALYZERS. ON 3-2-11, PRODUCT SURVEILLANCE PLACED A CALL TO THE FACILITY MANAGER. SHE STATED THAT THE PATIENT HAS BEEN HAVING AN ALLERGIC REACTION EVERY TIME SHE IS ON DIALYSIS. THE PATIENT STARTS TO HAVE RESPIRATORY PROBLEMS, PROBLEMS WITH BREATHING AND ANXIETY ABOUT 15-30 MINUTES INTO THERAPY. THE PATIENT HAS A HISTORY OF ASTHMA PROBLEMS. THE PATIENT WAS USING THE XENIUM 150 DIALYZERS AND HAD THE REACTION ABOUT 4 OR 5 TIMES. THE PATIENT WAS THEN SWITCHED OVER TO USING THE EXELTRA 150 DIALYZERS AND STILL HAD THE SAME REACTION ABOUT 3 TIMES. THEY STARTED TREATING THE PATIENT WITH BENADRYL BEFOREHAND, BUT THE PATIENT IS STILL SHOWING SOME OF THE SYMPTOMS. SHE STATED THAT THE DOCTOR DID NOT THINK THE REACTION MAY BE RELATED TO THE USE OF THE DIALYZERS. THE SAMPLE WAS DISCARDED BY THE CUSTOMER AND THERE ARE NO COMPANION SAMPLES AVAILABLE. THERE IS NO FURTHER INFORMATION AT THIS TIME.

    Description of Event or Problem · 1

    THE FOLLOWING ADDITIONAL/CLARIFIED INFORMATION WAS OBTAINED ON (B)(4) 2011 FROM THE FACILITY'S CLINICAL COORDINATOR (CC): THE CC INDICATED THAT THE FACILITY IS AN ACUTE CARE FACILITY AND THE PATIENT WAS ORIGINALLY ADMITTED TO THE SURGICAL CARDIOVASCULAR INTENSIVE CARE UNIT WITH HEART FAILURE AS THE DIAGNOSIS. THE CC INDICATED THAT ON (B)(6) 2011 THE PATIENT WAS STARTED ON HEMODIALYSIS TREATMENTS AND DID NOT EXHIBIT ANY SYMPTOMS UNTIL (B)(6) 2011, SUPPORTING THE PHYSICIAN'S OPINION THAT THE DIALYZERS ACTUALLY HAD NOTHING TO DO WITH THE PATIENT'S SYMPTOMS. THE CC INDICATED THAT WHEN THE PATIENT'S SYMPTOMS BEGAN, THEY SWITCHED HER FROM THE XENIUM TO THE EXELTRA DIALYZER TO DETERMINE WHETHER THE PATIENT WAS EXPERIENCING THE SYMPTOMS DUE TO HER HEART ISSUES AND THEY WERE ABLE TO RULE OUT THAT THE PATIENT WAS HAVING AN ALLERGIC REACTION AS THE SYMPTOMS CONTINUED. THE CC INDICATED THAT THE PATIENT'S HEART JUST COULD NOT HANDLE THE HEMODIALYSIS AND THE PATIENT PASSED AWAY ON (B)(6) 2011, CAUSE OF DEATH UNKNOWN. THE CC INDICATED THAT AN AUTOPSY WILL NOT BE PERFORMED. THERE IS NO ALLEGATION AGAINST THE PATIENT'S DIALYZERS. THE CC INDICATED THERE WAS NO FURTHER INFORMATION, INCLUDING LOT NUMBERS, AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XENIUM 150 SYNTH HF DIALYZERSYNTHETIC FOR HEMODIALYSIS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION USD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention