BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HMB32

    MDR report key: 11526966 · Received March 19, 2021

    Report

    Report Number
    1000312731-2021-00004
    Event Type
    Injury
    Date Received
    March 19, 2021
    Date of Event
    January 25, 2021
    Report Date
    April 14, 2021
    Manufacturer
    BELLCO SRL
    Product Code
    KPO
    UDI-DI
    38051411600061
    PMA / PMN Number
    K150966
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, THE PATIENT HAD AN INTERMITTENT HYPOKALEMIA THROUGHOUT THE HEMODIALYSIS TREATMENT. PATIENT WAS ON FUROSEMIDE ON 1/23 (5MG) AND 1/24 (13.5MG). IT WAS STATED THAT DIAGNOSTIC TESTS WERE PERFORMED BUT NO DIAGNOSTIC PROCEDURE PERFORMED. THE EVENT RESULTED IN PATIENT¿S TREATMENT BUT NO ADDITIONAL CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) SESSION WITH THE MACHINE. THE PATIENT WAS NOT TREATED WITH ADDITIONAL MECHANICAL VENTILATION OR SETTINGS ADJUSTED, NO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) INITIATED OR ADJUSTED, NOT TREATED WITH BLOOD PRODUCTS. IT WAS STATED THAT THE PATIENT WAS GIVEN AN UNSPECIFIED DOSAGE OF POTASSIUM CHLORIDE BOLUSES AND WAS ALSO ADDED TO DIALYSIS FLUID. THERE WAS NO OTHER MEDICATION GIVEN TO THE ASIDE FROM WHAT WAS MENTIONED. THE PROCEDURE WAS COMPLETED AND THE BLOOD WAS SAFELY RETURNED TO THE PATIENT. THERE WAS NO COMPONENT REPLACED. THERE WAS AN UNSPECIFIED MACHINE ALARM ACTIVATED. THE EVENT DID NOT LEAD TO DEATH, SERIOUS DETERIORATION IN THE HEALTH THAT RESULTED IN LIFE THREATENING ILLNESS OR INJURY, AND PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR BODY FUNCTION. THE EVENT DID NOT LEAD TO PATIENT¿S HOSPITALIZATION, MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION AND FETAL DISTRESS, FETAL DEATH OR A CONGENITAL ABNORMALITY OR BIRTH DEFECT. THE PATIENT WAS RECOVERED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, THE PATIENT HAD AN INTERMITTENT HYPOKALEMIA THROUGHOUT THE TREATMENT. PATIENT WAS ON FUROSEMIDE ON 1/23 (5MG) AND 1/24 (13.5MG). IT WAS STATED THAT DIAGNOSTIC TESTS WERE PERFORMED BUT NO DIAGNOSTIC PROCEDURE PERFORMED. THE EVENT RESULTED IN PATIENT¿S TREATMENT BUT NO ADDITIONAL CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) SESSION WITH THE MACHINE. THE PATIENT WAS NOT TREATED WITH ADDITIONAL MECHANICAL VENTILATION OR SETTINGS ADJUSTED, NO EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) INITIATED OR ADJUSTED, NOT TREATED WITH BLOOD PRODUCTS. IT WAS STATED THAT THE PATIENT WAS GIVEN POTASSIUM CHLORIDE BOLUSES AND WAS ALSO ADDED TO DIALYSIS FLUID. THE EVENT DID NOT LEAD TO DEATH, SERIOUS DETERIORATION IN THE HEALTH THAT RESULTED IN LIFE THREATENING ILLNESS OR INJURY, AND PERMANENT IMPAIRMENT OF A BODY STRUCTURE OR BODY FUNCTION. THE EVENT DID NOT LEAD TO PATIENT¿S HOSPITALIZATION, MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE-THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION AND FETAL DISTRESS, FETAL DEATH OR A CONGENITAL ABNORMALITY OR BIRTH DEFECT. THE PATIENT WAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425106 HMB32 DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO BELLCO SRL MD042 L120020019 38051411600061

    Patients

    Seq Age Sex Outcome Treatment
    1 432 DA Other