BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 11857999 · Received May 20, 2021

    Report

    Report Number
    3000219639-2021-00012
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    May 18, 2021
    Report Date
    May 20, 2021
    Manufacturer
    SALTER LABS
    Product Code
    CAT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT COULD NOT BE CONFIRMED BY FLOW TESTING BECAUSE THE PRODUCT WAS NOT RETURNED AND PICTURES WERE NOT PROVIDED. COMPLAINT HISTORY FOR THIS PART NUMBER WAS REVIEWED AND NO SIMILAR COMPLAINTS HAVE BEEN REPORTED. THIS ISSUE DOES NOT APPEAR TO BE TRENDING, BUT WILL CONTINUE TO BE MONITORED. AT THIS TIME, THE ISSUE APPEARS TO BE AN ISOLATED INCIDENT. THE MOST LIKELY ROOT CAUSE OF THIS ISSUE IS AN OCCLUSION CAUSED BY THE MEK BONDING MATERIAL. THE MEK BONDING PROCESS IS A MANUAL OPERATION AND VARIATIONS IN APPLICATION CAN SOMETIMES OCCUR. FLOW TESTING IS PERFORMED DURING THE FINAL QUALITY INSPECTION TO PREVENT THESE DEFECTS FROM ESCAPING. CUSTOMER FOLLOW UP BY FORMAL LETTER WAS SENT TO THE CUSTOMER VIA EMAIL. RA: THIS FAILURE MODE (R52) IS IDENTIFIED ON THE RISK ANALYSIS FILE (RA-11). THE SEVERITY OF HARM FOR THIS FAILURE MODE IS CONSIDERED A MAJOR (6) RISK AND DOES NOT MEET THE RISK THRESHOLD FOR CARB REVIEW (8).

    Description of Event or Problem · 0

    NURSE AT THE HOSPITAL NOTED THAT THE PATIENT'S SATURATION DIDN'T IMPROVE WHEN USING THE CANNULA. WHEN THE NURSE REMOVED THE CANNULA AND TRIED RUNNING SALINE THROUGH IT, A BLOCKAGE WAS NOTED. WHEN A NURSE TRIED TO DO AIR FLOW TO THE TUBE WITH 1611 PUTTING ON A PATIENT, SHE FOUND THAT SATURATION DIDN'T GO UP. A NURSE CHECKED IF AIR FLOW WORKED PROPERLY WITHOUT THE CANNULA. SHE COULD VERIFIED THERE WAS NO ISSUE. SO THE NURSE DOUBTED IT SHOULD HAVE A DEFECT ON THE CANNULA ITSELF. WHEN THE NURSE USED SALINE TO POUR INTO THE TUBE FOR CHECK, THE LIQUID WAS STACKED. TO CONSIDER THESE FACT, THE HOSPITAL JUDGED THAT CANNULA HAS DEFECT. THE CUSTOMER REQUIRED US TO INVESTIGATE THE ISSUE AND SUBMIT THE INVESTIGATION REPORT FROM THE MANUFACTURER.

    Additional Manufacturer Narrative · 1

    DUE TO THE BLOCKAGE THAT WAS FOUND IN THE CANNULA THE NURSE WAS NOT ABLE TO DELIVER OXYGEN TO THE PATIENT THEREFORE THEIR OXYGEN LEVEL DID NOT IMPROVE. THE TUBING WAS FOUND TO HAVE AN OCCLUSION LIKELY OCCURRING FROM THE MEK DIPPING BONDING PROCESS. THE CANNULA ASSEMBLY IS A MANUAL OPERATION WITH 6+ BONDS. LOW/NO MEK RESULTING IN A DISCONNECTION DOES OCCASIONALLY OCCUR. THIS RISK IS IDENTIFIED AND MITIGATED IN THE RISK ANALYSIS. BASED ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Description of Event or Problem · 1

    NURSE AT THE HOSPITAL NOTED THAT THE PATIENT'S SATURATION DIDN'T IMPROVE WHEN USING THE CANNULA. WHEN THE NURSE REMOVED THE CANNULA AND TRIED RUNNING SALINE THROUGH IT, A BLOCKAGE WAS NOTED. WHEN A NURSE TRIED TO DO AIR FLOW TO THE TUBE WITH 1611 PUTTING ON A PATIENT, SHE FOUND THAT SATURATION DIDN'T GO UP. A NURSE CHECKED IF AIR FLOW WORKED PROPERLY WITHOUT THE CANNULA. SHE COULD VERIFIED THERE WAS NO ISSUE. SO THE NURSE DOUBTED IT SHOULD HAVE A DEFECT ON THE CANNULA ITSELF. WHEN THE NURSE USED SALINE TO POUR INTO THE TUBE FOR CHECK, THE LIQUID WAS STACKED. TO CONSIDER THESE FACT, THE HOSPITAL JUDGED THAT CANNULA HAS DEFECT. THE CUSTOMER REQUIRED US TO INVESTIGATE THE ISSUE AND SUBMIT THE INVESTIGATION REPORT FROM THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    757247 SALTER LABS CANNULA, NEONATE, OXYGEN W/3-CHANNEL TUBE 7' - 50/CS CAT SALTER LABS 1611-7-50 SFT042218

    Patients

    Seq Age Sex Outcome Treatment
    1 Other