BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008T HD SYS. W/O CDX W/BIBAG BLUE STAR

    MDR report key: 15837406 · Received November 21, 2022

    Report

    Report Number
    0002937457-2022-02023
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    November 17, 2022
    Report Date
    January 9, 2023
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    KDI
    UDI-DI
    00840861102112
    PMA / PMN Number
    K173972
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    KEYSTONE DENTAL INC. PROVIDES LABELING WITH ALL IMPLANTS. FAILURE TO OSSEOINTEGRATE AND LOSS OF OSSEOINTEGRATION (IMPLANT MOBILITY) IS IDENTIFIED AS AN ADVERSE REACTION AND IDENTIFIED IN THE LIST OF WARNINGS IN ALL ENDOSSEOUS DENTAL IMPLANT LABELING. THE SPECIFIC CAUSE FOR A PARTICULAR COMPLAINT IS OFTEN NOT READILY IDENTIFIED AS THERE ARE VARIOUS FACTORS THAT CONTRIBUTE TO THE RISK OF IMPLANT FAILURE. THESE INCLUDE PATIENT FACTORS SUCH AS PRIOR ORAL INFECTION, POOR BONE QUALITY OR QUANTITY, SYSTEMIC CONDITIONS SUCH AS DIABETES AND UNCONTROLLED HYPERTENSION. TECHNIQUE FACTORS SUCH AS OVERHEATING OF THE IMPLANT SITE MAY CAUSE NECROSIS OF THE BONE, PREVENTING GROWTH (PELAYO ET AL., 2008; TURKYILMAZ & AL., 2008). PATIENT HABITS SUCH AS TOBACCO USE (HEITZ-MAYFIELD & HUYNH-BA, 2009), ALCOHOL OR DRUG ABUSE, POOR ORAL HYGIENE, AND BRUXISM (SALVI & BRAEGGER, 2009) MAY ALSO LEAD TO IMPLANT FAILURE. IN ADDITION, IMPROPER SURGICAL TECHNIQUE CAN LEAD TO IMPLANT FAILURE AND/OR LOSS OF SUPPORTING BONE (SALVI & BRAEGGER, 2009).

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5.

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE COMPONENT WAS NOT RETURNED; A PHYSICAL INVESTIGATION WAS NOT PERFORMED. INVESTIGATION DETERMINES THAT THERE WAS CAUSAL RELATIONSHIP BETWEEN THE OBJECTIVE EVIDENCE (PHOTO) AND THE ALLEGED EVENT; THE ALLEGED EVENT IS CONFIRMED. 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 ABLE TO CONFIRM THE REPORTED FAILURE MODE. THE COMPLAINT EVENT WAS CONFIRMED.

    Description of Event or Problem · 0

    A FRESENIUS FIELD SERVICE TECHNICIAN (FST) REPORTED THAT A 2008T MACHINE HAD AN OUT OF BOX POWER UP FAILURE AND THE SCREEN WENT OUT. IT WAS NOTICED THAT THERE WAS AN INTENSE BURN SMELL. THERE WAS NO PATIENT INVOLVEMENT OR PATIENT HARM REPORTED. UPON FOLLOW-UP, THE CLINIC MANAGER (CM) STATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT, AND A BURNT MOTHERBOARD AND BURNING SMELL WAS NOTED WHEN THE MACHINE WAS FIRST POWERED UP. THE CM STATED THE SCREEN WAS ALSO NON-FUNCTIONAL. PER CM THE MACHINE WILL BE RETURNED UPON RECEIPT OF A REPLACEMENT MACHINE. THE FST HAD REPORTED DURING THE INITIAL POWER ON OF THE HEMODIALYSIS MACHINE, THE MACHINE DISPLAY STARTED TO FLICKER AND THEN WENT COMPLETELY BLACK. A STRONG BURNING SMELL IMMEDIATELY WAS NOTICED AND THE MACHINE WAS THEN UNPLUGGED. FURTHER INSPECTION REVEALED A BURNED COMPONENT ON THE MOTHERBOARD. BOTH THE CUSTOMER BIOMEDICAL TECHNICIAN (BMT) AND FST REFUSED TO REPAIR OR INSTALL THE MACHINE DUE TO THE NATURE OF THE BURN DAMAGE. THE MACHINE WAS SET UP TO BE RETURNED TO MANUFACTURING.

    Description of Event or Problem · 0

    A FRESENIUS FIELD SERVICE TECHNICIAN (FST) REPORTED THAT A 2008T MACHINE HAD AN OUT OF BOX POWER UP FAILURE AND THE SCREEN WENT OUT. IT WAS NOTICED THAT THERE WAS AN INTENSE BURN SMELL. THERE WAS NO PATIENT INVOLVEMENT OR PATIENT HARM REPORTED. UPON FOLLOW-UP, THE CLINIC MANAGER (CM) STATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT, AND A BURNT MOTHERBOARD AND BURNING SMELL WAS NOTED WHEN THE MACHINE WAS FIRST POWERED UP. THE CM STATED THE SCREEN WAS ALSO NON-FUNCTIONAL. PER CM THE MACHINE WILL BE RETURNED UPON RECEIPT OF A REPLACEMENT MACHINE. THE FST HAD REPORTED DURING THE INITIAL POWER ON OF THE HEMODIALYSIS MACHINE, THE MACHINE DISPLAY STARTED TO FLICKER AND THEN WENT COMPLETELY BLACK. A STRONG BURNING SMELL IMMEDIATELY WAS NOTICED AND THE MACHINE WAS THEN UNPLUGGED. FURTHER INSPECTION REVEALED A BURNED COMPONENT ON THE MOTHERBOARD. BOTH THE CUSTOMER BIOMEDICAL TECHNICIAN (BMT) AND FST REFUSED TO REPAIR OR INSTALL THE MACHINE DUE TO THE NATURE OF THE BURN DAMAGE. THE MACHINE WAS SET UP TO BE RETURNED TO MANUFACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1327501 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI CONCORD MANUFACTURING 191130 00840861102112

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown