BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIASYS

    MDR report key: 1912713 · Received November 19, 2010

    Report

    Report Number
    2021710-2010-00057
    Event Type
    Malfunction
    Date Received
    November 19, 2010
    Date of Event
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    CAREFUSION
    Product Code
    CBK
    PMA / PMN Number
    K013642
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS ORIGINALLY DETERMINED TO BE NON-REPORTABLE ON (B)(4) 2010. ON (B)(4) 2010, WE RECEIVED A USER FACILITY MEDWATCH REPORT FROM THE FDA CONCERNING THIS EVENT. BASED ON THAT MEDWATCH REPORT, WE WILL SUBMIT A MANUFACTURER'S MEDWATCH REPORT FOR THIS EVENT TO THE FDA. THE USER FACILITY DID NOT PROVIDE ANY PATIENT OR DEVICE CODES ON THEIR USER FACILITY REPORT. CODES WERE DERIVED BASED ON THE INFORMATION PROVIDED BY THE USER FACILITY IN BLOCK B5 OF THE USER FACILITY MEDWATCH REPORT RECEIVED FROM THE FDA ON (B)(4)2010. THE FOLLOWING INFORMATION CONCERNING THE EVALUATION OF THE DEVICE IS A SUMMARY OF THE INFORMATION DOCUMENTED BY THE (B)(4) FAILURE ANALYSIS LAB TECH. THE (B)(4) FAILURE ANALYSIS LAB TECH EVALUATED THE NEBULIZER ASSEMBLY AND VERIFIED THE COMPLAINT. THE (B)(4) FAILURE ANALYSIS LAB TECH DETERMINED THAT THE ROOT CAUSE OF THE ASSEMBLY'S FAILURE WAS MOST LIKELY DUE TO AN OUT OF SPECIFICATION INNER CYLINDER DIAMETER OF THE NEBULIZER MANIFOLD BLOCK PN: (B)(4). THIS SPECIFICATION DISCREPANCY APPEARS TO HAVE CAUSED THE PISTON AND SEAL PN: (B)(4) TO GRIND AGAINST THE INNER WALL OF THE CYLINDER RESULTING IN THE SEAL BECOMING PLIABLE. (B)(4) HAS INITIATED AN INTERNAL CORRECTIVE ACTION REQUEST THROUGH OUR CORRECTIVE AND PREVENTATIVE ACTION SYSTEM TO ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    THE FOLLOWING DESCRIPTION OF THE EVENT WAS DOCUMENTED BY A (B)(4) TECH SUPPORT SPECIALIST IN RESPONSE TO A PHONE CONVERSATION WITH A USER FACILITY REPRESENTATIVE. "[NAME REMOVED] IS THE BIOMED, HE IS AVEA TRAINED. THIS PROBLEM WAS ORIGINALLY CALLED IN ON CALL (B)(4) 2010. PROBLEM IS THEY SEE A "BLACK DUST" COMING OUT OF THE NEB PORT WHEN TURNED ON. [NAME REMOVED] JUST PURCHASED AND INSTALLED A NEW NEB. VENT AND NEW NEB ARE WORKING GOOD. NO PATIENT INVOLVEMENT. HE SAID THAT HE HAS PULLED OFF THE TOP CAP OF THE BAD NEB AND A BUNCH OF "BLACK DUST" CAME OUT. HE SAID THAT THE OUTPUT HOSE WAS COATED WITH IT BUT THE INPUT HOSES WERE BOTH CLEAN. HE SAID THE RT STAFF HAS BEEN TOLD TO NOT USE THE NEB ON AVEA VENTS [NAME REMOVED] SAID HE IS TAKING PICTURES OF THIS "DUST" AND SENDING THEM TO OTHER BIOMEDS AS WELL AS THEIR HOSP QA PEOPLE. EXPLAINED THAT WE NEED THE BAD NEB SENT BACK ON RGA (B)(4) TO(B)(4) SO OUR ENGINEERING STAFF CAN ANALYSE IT. HE WILL PUT CAP BACK ON AND RETURN ON RGA." THE FOLLOWING DESCRIPTION OF THE EVENT WAS COPIED FROM THE USER FACILITY MEDWATCH REPORT RECEIVED BY (B)(4) ON (B)(4) 2010 FROM THE FDA. WHEN THE VENTILATOR CAME INTO THE SHOP FOR ROUTINE SERVICE, A BLACK DUST WAS NOTED IN THE NEBULIZER TUBING LEADING TO THE PATIENT CIRCUIT. THIS IS THE SECOND INSTANCE IN 3 YEARS WHERE THIS SYMPTOM WAS NOTED IN THE AVEA VENTILATOR. THE BIOMEDICAL ENGINEER (BIOMED) SUSPECTS SOME TYPE OF DETERIORATION INSIDE THE NEBULIZER PUMP ASSEMBLY. THE BIOMED HAS CONCERNS THAT THERE IS NO RECOMMENDED FILTER ON THE NEBULIZER PORT TO CATCH/STOP THIS DUST FROM GOING INTO THE PATIENT CIRCUIT. HEALTH PROFESSIONAL'S IMPRESSION: DETERIORATION OF A SEAL INSIDE THE NEBULIZER ASSEMBLY IS CREATING A BLACK DUST THAT FINDS ITS WAY INTO THE PATIENT CIRCUIT AND ULTIMATELY INTO THE PATIENT. MANUFACTURER RESPONSE FOR VENTILATOR, AVEA: WE HAVE COMPLETED THE INVESTIGATION OF THE RETURNED NEBULIZER FROM (B)(4). OUR FINDINGS ARE AS FOLLOWS: FAILURE ANALYSIS: VERIFIED THE REPORTED ISSUE, THE ASSEMBLY WAS FULLY DISASSEMBLED AND FOUND "BLACK DUST" INTERNALLY. THIS DUST WAS FROM THE SEAL AROUND THE INNER PISTON ASSEMBLY. THE CAUSE OF THIS WAS MOST LIKELY DUE TO AN OUT OF SPECIFICATION INNER CYLINDER DIAMETER NEB HOUSING (B)(4). THIS SPECIFICATION DISCREPANCY CAUSED THE PISTON AND SEAL (P#(B)(4)) TO GRIND AGAINST THE INNER CYLINDER RESULTING IN THE SEAL BECOMING PLIABLE AND RUBBING AGAINST THE INNER WALL. SINCE BOTH THE PISTON ASSEMBLY AND THE INNER SURFACE OF THE CYLINDER BLOCK ARE PHYSICALLY DAMAGED, NO MEASUREMENTS COULD BE TAKEN. FINDINGS/ROOT-CAUSE: POSSIBLE BORING ISSUE OF THE NEBULIZER MANIFOLD BLOCK P# (B)(4). NO RECOMMENDATIONS FOR PREVENTION OR SAFETY PRECAUTIONS FOR THE PATIENT (FILTER ON THE NEBULIZER PORT) WERE GIVEN. SEE SCANNED PAGE. DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIASYS VENTILATOR, CONTINUOUS, FACILITY USE / CBK CBK CAREFUSION AVEA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other