BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS

    MDR report key: 6086021 · Received November 8, 2016

    Report

    Report Number
    2937457-2016-01138
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    July 26, 2016
    Report Date
    December 8, 2016
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE 2008K2 HEMODIALYSIS (HD) MACHINE WAS REMOVED FROM SERVICE FOLLOWING A ¿HIGH TEMPERATURE¿ ALARM AND EVALUATED BY THE ON-SITE BIOMEDICAL TECHNICIAN. THE BIOMED FOUND THE POWER CONTROL BOARD (PCB) HAD HEAT DAMAGE, AS EVIDENCED BY THE PRESENCE OF A BURN MARK. THE BIOMED REPLACED THE PCB WHICH RESOLVED THE ISSUE. FUNCTIONAL TESTING PERFORMED BY THE BIOMED CONFIRMED THE SYSTEM WAS OPERATING PROPERLY. THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY WITHOUT A RECURRENCE OF THE EVENT. THE PCB WAS RECEIVED BY THE MANUFACTURER FOR ANALYSIS. A VISUAL EXAMINATION WAS PERFORMED WHICH REVEALED THE PRESENCE OF HEAT DAMAGE TO RESISTORS R10 AND R11 ON THE PCB. NO OTHER DAMAGE OR DEFICIENCIES TO THE PCB WERE IDENTIFIED. FUNCTIONAL TESTING WAS PERFORMED BY INSTALLING THE RECEIVED COMPONENT INTO A WORKING UNIT. THE MACHINE GENERATED A ¿HIGH TEMPERATURE¿ ALARM WITH THE DAMAGED PCB INSTALLED. THE DAMAGED RESISTORS (R10 AND R11) WERE REPLACED WITH NEW COMPONENTS, AND THEN THE UNIT WAS RE-TESTED. THE UNIT PASSED THE SELF-TEST AND THE DIASAFE FILTER INTEGRITY TEST WITH THE PART INSTALLED. ADDITIONALLY, THE UNIT WAS PUT THROUGH A RINSE CYCLE, AND A CHEMICAL/HEAT DISINFECT CYCLE; ALL CYCLES COMPLETED WITHOUT ISSUE. 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 DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE LABELING AND QC TESTING RESULTS WERE WITHIN SPECIFICATION. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS ABLE TO CONFIRM THE REPORTED EVENT. THE RES PERFORMED A VISUAL EXAMINATION OF THE RETURNED BOARD WHICH IDENTIFIED DAMAGED RESISTORS (R10 AND R11) ON THE PCB. THE OBSERVED DAMAGED LED TO THE ¿HIGH TEMPERATURE¿ ALARM REPORTED BY THE COMPLAINANT. THEREFORE, THE COMPLAINT HAS BEEN DEEMED CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE POWER CONTROL BOARD WAS RETURNED TO THE MANUFACTURER FOR EXAMINATION AND ANALYSIS. THE MANUFACTURER'S INVESTIGATION IS CURRENTLY IN PROGRESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 1

    FRESENIUS MEDICAL CARE CONCORD FACILITY RECEIVED A POWER CONTROL BOARD VIA A RETURNED GOODS AUTHORIZATION (RGA) THAT WAS RETURNED FOR CREDIT FOR EXCHANGED GOODS. THE RG PERSONNEL NOTICED THAT THE POWER CONTROL BOARD HAD A BURN MARK, INDICATIVE OF EXCESSIVE HEAT DAMAGE. THE BIOMEDICAL TECHNICIAN (BIOMED) WAS CONTACTED AT THE USER FACILITY. THE BIOMED STATED THAT THE 2008K2 HEMODIALYSIS (HD) MACHINE WAS ORIGINALLY PULLED FROM THE FLOOR FOR HIGH TEMPERATURE ON (B)(6) 2016. THE BIOMED CONFIRMED NO PATIENT INVOLVEMENT. WHILE TROUBLESHOOTING THE SYSTEM, THE BIOMED FOUND A BURN MARK ON THE POWER CONTROL BOARD. NO BURNING SMELL, SMOKE, FIRE, FLAMES, OR SPARKS WERE OBSERVED. NO OTHER COMPONENTS WERE FOUND TO BE DAMAGED. THE BIOMED REPLACED THE POWER CONTROL BOARD TO RESOLVE THE ISSUE. THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT A RECURRENCE OF THE EVENT AS REPORTED. THE POWER CONTROL BOARD WAS MADE AVAILABLE TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    FRESENIUS MEDICAL CARE CONCORD FACILITY RECEIVED A POWER CONTROL BOARD VIA A RETURNED GOODS AUTHORIZATION (RGA) THAT WAS RETURNED FOR CREDIT FOR EXCHANGED GOODS. THE RG PERSONNEL NOTICED THAT THE POWER CONTROL BOARD HAD A BURN MARK, INDICATIVE OF EXCESSIVE HEAT DAMAGE. THE BIOMEDICAL TECHNICIAN (BIOMED) WAS CONTACTED AT THE USER FACILITY. THE BIOMED STATED THAT THE 2008K2 HEMODIALYSIS (HD) MACHINE WAS ORIGINALLY PULLED FROM THE FLOOR FOR HIGH TEMPERATURE ON (B)(6) 2016. THE BIOMED CONFIRMED NO PATIENT INVOLVEMENT. WHILE TROUBLESHOOTING THE SYSTEM, THE BIOMED FOUND A BURN MARK ON THE POWER CONTROL BOARD. NO BURNING SMELL, SMOKE, FIRE, FLAMES, OR SPARKS WERE OBSERVED. NO OTHER COMPONENTS WERE FOUND TO BE DAMAGED. THE BIOMED REPLACED THE POWER CONTROL BOARD TO RESOLVE THE ISSUE. THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT A RECURRENCE OF THE EVENT AS REPORTED. THE POWER CONTROL BOARD WAS MADE AVAILABLE TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736991 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING 2008K2

    Patients

    Seq Age Sex Outcome Treatment
    1