BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLUX AV 1000 S

    MDR report key: 14312702 · Received May 6, 2022

    Report

    Report Number
    3002807005-2022-00010
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    March 1, 2022
    Report Date
    July 2, 2022
    Manufacturer
    FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH
    Product Code
    KDI
    PMA / PMN Number
    EUA200149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL REVIEW: THERE WAS NO REPORT THIS PATIENT EXPERIENCED A SERIOUS INJURY OR ADVERSE EVENT AS A RESULT OF ABNORMAL LAB VALUES. MEDICAL INTERVENTION FOR THIS EVENT INCLUDED CHANGING THE TREATMENT SET YET IT WAS AFFIRMED THIS WAS DONE TO NORMALIZE LAB VALUES WITH NO INDICATION THIS EXCHANGE WAS TO REVERSE ANY HARMFUL EFFECTS OF THE SUSPECTED CLOGGING. PRESENTLY THERE IS NO OBJECTIVE EVIDENCE INDICATING A SERIOUS INJURY, PATIENT DEATH, OR OTHER ADVERSE EVENT(S) OCCURRED RELATED TO ANY FRESENIUS PRODUCT(S) OR DEVICE(S) WARRANTING FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G1 THE EVENT REPORTED ON IS NOT REPORTABLE. ACCORDING TO THE MANUFACTURING, DURING THE COURSE OF THE INVESTIGATION IT WAS LEARNED THAT THIS INCIDENT WAS BASED ON FALSE INFORMATION. THE INCORRECT NUMBER OF EVENTS WAS REPORTED AND THIS EVENT IS THEREFORE BEING VOIDED. THERE WILL BE NO FURTHER UPDATES ON .

    Description of Event or Problem · 0

    IT WAS REPORTED TO FRESENIUS VIA A MANUFACTURER INCIDENT REPORT (MIR) THAT A PATIENT ON CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON THE MULTIFILTRATEPRO WITH THE ULTRAFLUX AV 1000S DIALYZER EXPERIENCED ABNORMAL LAB VALUES FOLLOWING A SUSPECTED CLOGGING OF THE ULTRAFLUX AV 1000S DIALYZER. THE PATIENT'S ESTIMATED BLOOD LOSS VOLUME DUE TO THE SUSPECTED CLOGGING WAS UNKNOWN. FURTHER REVIEW OF THE MIR REVEALED THAT THE LOCAL FRESENIUS MEDICAL CARE ORGANIZATION RECEIVED A REPORT REGARDING POTENTIAL CLOGGING EVENTS THAT OCCURRED WITH AN ULTRAFLUX AV 1000S DIALYZER AND MULTIFILTRATEPRO CRRT MACHINE. DURING 4 TREATMENTS WITH THE MULTIFILTRATEPRO, CLOGGING OCCURRED ALMOST SIMULTANEOUSLY IN THE INTENSIVE CARE UNIT OF (B)(6) HOSPITAL. ALL CASES SHOWED AN INCREASE IN BICARBONATE (HCO3-) AND A CLINICALLY RELEVANT REDUCTION IN CALCIUM (CA+) SUBSTITUTION SIMULTANEOUSLY WITH AN INCREASE IN SODIUM (NA+). CRRT TREATMENTS WERE DISCONTINUED AS THE PATIENT¿S HCO3- WAS GREATER THAN 40 MMOL/L. THE TREATMENT SETS ON THE MULTIFILTRATEPRO WERE EXCHANGED AND BICARBONATE VALUES DECREASED (EXACT VALUE UNKNOWN). TREATMENT SETTINGS FOR THIS PATIENT WERE ACCORDING TO PROTOCOL, INCLUDING RECOMMENDED COUNTERMEASURES. THE EXACT DATE OF THIS EVENT WAS NOT PROVIDED. ADDITIONAL ATTEMPTS MADE BY FRESENIUS MEDICAL CARE (SCHWEIZ) AG TO OBTAIN PATIENT INFORMATION, FURTHER DETAILS OF THE EVENTS, TREATMENT DATA, CAUSALITY OF EVENTS AND CURRENT DISPOSITIONS OF THESE PATIENTS PROVED UNSUCCESSFUL. IN THE REPORTING, THE EXACT VALUES OF CA+ AND NA+ WERE NOT PROVIDED AND A DETERMINATION OF SEVERITY OF THESE LAB VALUES CANNOT BE CONCLUDED. THOUGH HCO3- WAS ELEVATED TO 40 MMOL/L, THERE WAS NO INDICATION THE PATIENT DEVELOPED ALKALOSIS PRIOR TO THE REDUCTION OF HCO3- BY CHANGING THE TREATMENT SET. NO SAMPLE IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED TO FRESENIUS VIA A MANUFACTURER INCIDENT REPORT (MIR) THAT A PATIENT ON CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON THE MULTIFILTRATEPRO WITH THE ULTRAFLUX AV 1000S DIALYZER EXPERIENCED ABNORMAL LAB VALUES FOLLOWING A SUSPECTED CLOGGING OF THE ULTRAFLUX AV 1000S DIALYZER. THE PATIENT'S ESTIMATED BLOOD LOSS VOLUME DUE TO THE SUSPECTED CLOGGING WAS UNKNOWN. FURTHER REVIEW OF THE MIR REVEALED THAT THE LOCAL FRESENIUS MEDICAL CARE ORGANIZATION RECEIVED A REPORT REGARDING POTENTIAL CLOGGING EVENTS THAT OCCURRED WITH AN ULTRAFLUX AV 1000S DIALYZER AND MULTIFILTRATEPRO CRRT MACHINE. DURING 4 TREATMENTS WITH THE MULTIFILTRATEPRO, CLOGGING OCCURRED ALMOST SIMULTANEOUSLY IN THE INTENSIVE CARE UNIT OF MÜNSTERLINGEN CANTONAL HOSPITAL. ALL CASES SHOWED AN INCREASE IN BICARBONATE (HCO3-) AND A CLINICALLY RELEVANT REDUCTION IN CALCIUM (CA+) SUBSTITUTION SIMULTANEOUSLY WITH AN INCREASE IN SODIUM (NA+). CRRT TREATMENTS WERE DISCONTINUED AS THE PATIENT¿S HCO3- WAS GREATER THAN 40 MMOL/L. THE TREATMENT SETS ON THE MULTIFILTRATEPRO WERE EXCHANGED AND BICARBONATE VALUES DECREASED (EXACT VALUE UNKNOWN). TREATMENT SETTINGS FOR THIS PATIENT WERE ACCORDING TO PROTOCOL, INCLUDING RECOMMENDED COUNTERMEASURES. THE EXACT DATE OF THIS EVENT WAS NOT PROVIDED. ADDITIONAL ATTEMPTS MADE BY FRESENIUS MEDICAL CARE (SCHWEIZ) AG TO OBTAIN PATIENT INFORMATION, FURTHER DETAILS OF THE EVENTS, TREATMENT DATA, CAUSALITY OF EVENTS AND CURRENT DISPOSITIONS OF THESE PATIENTS PROVED UNSUCCESSFUL. IN THE REPORTING, THE EXACT VALUES OF CA+ AND NA+ WERE NOT PROVIDED AND A DETERMINATION OF SEVERITY OF THESE LAB VALUES CANNOT BE CONCLUDED. THOUGH HCO3- WAS ELEVATED TO 40 MMOL/L, THERE WAS NO INDICATION THE PATIENT DEVELOPED ALKALOSIS PRIOR TO THE REDUCTION OF HCO3- BY CHANGING THE TREATMENT SET. NO SAMPLE IS EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1099898 ULTRAFLUX AV 1000 S DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH C2BE31100

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown MULTIFILTRATEPRO MACHINE| MULTIFILTRATEPRO MACHINE