BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COLLECTIVE CONCENTRATE- NATURALYTE

    MDR report key: 8578592 · Received May 3, 2019

    Report

    Report Number
    3005162618-2019-00005
    Event Type
    Injury
    Date Received
    May 3, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 6, 2019
    Manufacturer
    OREGON MANUFACTURING PLANT
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED ON THE PRODUCTS SHIPPED TO THE CUSTOMER FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. IT WAS DETERMINED BY THE OREGON CONCENTRATES MANUFACTURING SITE BASED ON THE DOCUMENTED ACTIVITY NOTES THAT SODIUM BICARBONATE CARTON PRODUCTS WOULD NOT BE WITHIN THE SCOPE OF THIS COMPLAINT SINCE IT REFERENCES THE ACETATE PRODUCT NATURALYTE. ALL PRODUCT DHR¿S SHIPPED TO THE CUSTOMER PRODUCED BY THE IRVING CONCENTRATES MANUFACTURING SITE WERE REVIEWED AND VERIFIED TO BE WITHIN SPECIFICATION BEFORE RELEASE . THERE WAS ONE NONCONFORMANCE FOUND ON ONE LOT RELATED TO FOREIGN MATERIAL. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE PRODUCT LOTS INVOLVED MET ALL SPECIFICATIONS FOR RELEASE. A REVIEW OF THE DHR DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    A TEMPORAL RELATIONSHIP EXISTS BETWEEN CCPD THERAPY UTILIZING COLLECTIVE CONCENTRATE ¿ NATURALYTE, THE OPTIFLUX 160NR DIALYZER AND THE ADVERSE EVENT(S) OF ASTHMA LIKE SYMPTOMS, CHARACTERIZED BY WHEEZING, SHORTNESS OF BREATH, COUGHING AND CHEST PAIN. PER THE PDRN THE ETIOLOGY OF EVENT(S) IS UNKNOWN; THEREFORE, CAUSALITY CANNOT BE FIRMLY ESTABLISHED. BASED ON THE INFORMATION AVAILABLE, THE COLLECTIVE CONCENTRATE ¿ NATURALYTE AND THE OPTIFLUX 160NR DIALYZER CANNOT BE DISASSOCIATED FROM THE EVENT(S). GIVEN THE NEED FOR PRE-MEDICATION TO PRECLUDE THE ONSET OF SYMPTOMS DURING HD THERAPY, A POSSIBLE CAUSAL OR CONTRIBUTORY ROLE CANNOT BE RULED OUT. WHILE UNCOMMON, HYPERSENSITIVITY REACTIONS ARE KNOWN TO OCCUR WITH USE OF OPTIFLUX DIALYZERS. ADDITIONALLY, HYPERSENSITIVITY REACTIONS HAVE BEEN KNOWN TO OCCUR DAYS, MONTHS, EVEN YEARS AFTER USE WITH THE SAME DIALYZER MODEL. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 1

    A HEMODIALYSIS REGISTERED NURSE (HDRN) FOR A PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HD FOR RENAL REPLACEMENT THERAPY (RRT) REPORTED THE PATIENT HAS BEEN EXPERIENCING ¿ASTHMA LIKE¿ SYMPTOMS DURING HD THERAPY (INITIALLY DOCUMENTED AS POST-TREATMENT) FOR TWO MONTHS (DATES NOT PROVIDED) AT SEVERAL DIFFERENT CLINICS. DURING FOLLOW-UP, THE HDRN STATED THE SYMPTOMS (E.G. WHEEZING, SHORTNESS OF BREATH, COUGHING AND CHEST PAIN) WERE MILD AT FIRST, HOWEVER THEY HAVE GOTTEN PROGRESSIVELY WORSE. EMERGENCY MEDICAL SERVICES WAS CALLED ON 1 OR 2 OCCASIONS; HOWEVER, SPECIFIC DATES OR ADDITIONAL DETAILS WERE NOT PROVIDED. THE PATIENT RECENTLY SAW A PULMONARY SPECIALIST AND WAS PLACED ON A STEROID INHALER (DRUG, DOSAGE, FREQUENCY NOT PROVIDED). THE PATIENT IS CURRENTLY UTILIZING THE STEROID INHALER AND A NEBULIZER TREATMENT PRIOR TO HD THERAPY. HOWEVER, THIS IS NOT A LONG-TERM SOLUTION. ADDITIONALLY, THE PATIENT SELF-MEDICATES WITH BENADRYL (DOSAGE NOT PROVIDED) PRIOR TO THE START OF EACH HD TREATMENT. THE PATIENT HAS BEEN ON HD FOR 1 YEAR AND 1 MONTH WHEN THESE SYMPTOMS STARTED OCCURRING AND FELT THERE MAY BE SOME CORRELATION. THE PATIENT WAS SCHEDULED TO SEE AN ALLERGIST FOR AN ACETATE PATCH TEST ON (B)(6) 2019, HOWEVER DURING FOLLOW-UP ON (B)(6) 2019, THE HDRN STATED THE PATIENT LEFT TOWN AND CONTINUED THE USE OF THEIR REGULAR PRE-TREATMENT MEDICATIONS TO PREVENT A REACTION WHILE TRAVELING. THE ACETATE PATCH TEST WAS RESCHEDULED, SO THE PATIENT COULD DISCONTINUE UTILIZING THE STEROID INHALER. REPORTEDLY BOTH THE NEPHROLOGIST AND HDRN FEEL THE PATIENT IS HAVING AN ALLERGIC REACTION TO THE OPTIFLUX 160NR DIALYZER AND ARE ATTEMPTING TO OBTAIN ADDITIONAL DIALYZERS TO TRIAL. DURING FOLLOW-UP, THE HDRN STATED DUE TO THE PATIENT¿S VACATION, NO ALTERNATIVE DIALYZERS WERE TRAILED. CURRENTLY THE DIALYSIS STAFF IS PERFORMING AN EXTRA RINSE TO ATTEMPT TO MINIMIZE ANY CHANGE OF A HYPERSENSITIVITY REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372257 COLLECTIVE CONCENTRATE- NATURALYTE DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO OREGON MANUFACTURING PLANT

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention FRESENIUS DIALYZER| FRESENIUS DIALYZER