BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRY ACID 132 GALLON UNIT, ASSY TO SHIP

    MDR report key: 11435938 · Received March 8, 2021

    Report

    Report Number
    2937457-2021-00375
    Event Type
    Malfunction
    Date Received
    March 8, 2021
    Date of Event
    February 15, 2021
    Report Date
    March 31, 2021
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KPO
    UDI-DI
    00840861100996
    PMA / PMN Number
    K131611
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: A DISPLAY BOARD ASSEMBLY (PART NUMBER 160068) WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. INSPECTION OF THE RECEIVED DISPLAY BOARD ASSEMBLY FOUND BURN DAMAGE TO COMPONENTS U2 (UCN5832A, 40 PIN, 32 BIT SERIAL INPUT, LATCHED DRIVERS) AND U10 (LM358N, 8 PIN, DUAL OPERATIONAL AMPLIFIERS). DEBRIS FROM THE BURNED COMPONENTS COATED THE BOARD NEAR THE BURN DAMAGE. SIMULATED TESTING COULD NOT BE PERFORMED DUE TO THE OBSERVED DAMAGE. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS ABLE TO CONFIRM THE REPORTED FAILURE MODE. DURING VISUAL INSPECTION OF THE RETURNED PART, THERMAL DAMAGE WAS IDENTIFIED. THEREFORE, THE COMPLAINT EVENT IS CONFIRMED.

    Description of Event or Problem · 0

    A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT ONE OF THE CHIPS ON THE CONTROL BOARD ASSEMBLY OF A DRY ACID 132-GALLON MIXER, CAUGHT ON FIRE. THE BIOMED WAS REPORTEDLY REPLACING THE CONTROL BOARD FOR THE MIXER BECAUSE THE ONE IN THE MACHINE WAS NOT WORKING CORRECTLY; IT WAS NOT SHUTTING OFF THE DRAIN. AFTER REPLACING THE CONTROL BOARD, AS SOON AS THE BIOMED PLUGGED IN THE ACID MIXER, THE ¿BIG CHIP¿ ON THE NEW CONTROL BOARD CAUGHT ON FIRE. THE BIOMED STATED THE FLAME WAS VERY SMALL. BURN DAMAGE AND MELTING WAS PRESENT ON THE SURROUNDING AREA OF THE BOARD. AFTER THE FLAME DIED AND THE FIRE WENT OUT, SMOKE WAS EMITTED FROM THE PROBLEM ARE OF THE BOARD. A BURNING SMELL REMAINED PRESENT IN THE ROOM THAT THE MACHINE WAS HOUSED IN ¿FOR A FEW HOURS¿. THE BIOMED STATED THEY WERE ABLE TO REMOVE THE DAMAGED BOARD FROM THE BUILDING QUICKLY ENOUGH TO PREVENT THE SMOKE DETECTOR(S) FROM GOING OFF. THE BIOMED BELIEVED THAT THE BIG CHIP ON THE BOARD WAS FAULTY. THEY REINSTALLED THE OTHER CONTROL BOARD AND HAVE CONTINUED TO USE THE MACHINE. THE BIOMED ORDERED A REPLACEMENT CONTROL BOARD AND WAS WAITING FOR THE PART AT THE TIME OF FOLLOW-UP. ONCE THEY RECEIVE THE REPLACEMENT, THEY STATED THEY WOULD RETURN THE DAMAGED BOARD FOR EVALUATION. PHOTOS OF THE DAMAGED BOARD WERE PROVIDED BY THE BIOMED. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: ALTHOUGH A SAMPLE WAS REPORTED TO BE AVAILABLE FOR MANUFACTURER EVALUATION, TO DATE NO SAMPLE HAS BEEN RECEIVED. ADDITIONALLY, NO ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS FIELD SERVICE TECHNICIAN (FST). A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Description of Event or Problem · 1

    A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT ONE OF THE CHIPS ON THE CONTROL BOARD ASSEMBLY OF A DRY ACID 132-GALLON MIXER, CAUGHT ON FIRE. THE BIOMED WAS REPORTEDLY REPLACING THE CONTROL BOARD FOR THE MIXER BECAUSE THE ONE IN THE MACHINE WAS NOT WORKING CORRECTLY; IT WAS NOT SHUTTING OFF THE DRAIN. AFTER REPLACING THE CONTROL BOARD, AS SOON AS THE BIOMED PLUGGED IN THE ACID MIXER, THE BIG CHIP ON THE NEW CONTROL BOARD CAUGHT ON FIRE. THE BIOMED STATED THE FLAME WAS VERY SMALL. BURN DAMAGE AND MELTING WAS PRESENT ON THE SURROUNDING AREA OF THE BOARD. AFTER THE FLAME DIED AND THE FIRE WENT OUT, SMOKE WAS EMITTED FROM THE PROBLEM ARE OF THE BOARD. A BURNING SMELL REMAINED PRESENT IN THE ROOM THAT THE MACHINE WAS HOUSED IN FOR A FEW HOURS. THE BIOMED STATED THEY WERE ABLE TO REMOVE THE DAMAGED BOARD FROM THE BUILDING QUICKLY ENOUGH TO PREVENT THE SMOKE DETECTOR(S) FROM GOING OFF. THE BIOMED BELIEVED THAT THE BIG CHIP ON THE BOARD WAS FAULTY. THEY REINSTALLED THE OTHER CONTROL BOARD AND HAVE CONTINUED TO USE THE MACHINE. THE BIOMED ORDERED A REPLACEMENT CONTROL BOARD AND WAS WAITING FOR THE PART AT THE TIME OF FOLLOW-UP. ONCE THEY RECEIVE THE REPLACEMENT, THEY STATED THEY WOULD RETURN THE DAMAGED BOARD FOR EVALUATION. PHOTOS OF THE DAMAGED BOARD WERE PROVIDED BY THE BIOMED. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336316 DRY ACID 132 GALLON UNIT, ASSY TO SHIP DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO CONCORD MANUFACTURING 160147 00840861100996

    Patients

    Seq Age Sex Outcome Treatment
    1