BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEONATAL PATIENT CIRCUIT KIT

    MDR report key: 5092070 · Received September 21, 2015

    Report

    Report Number
    2050001-2015-00024
    Event Type
    Injury
    Date Received
    September 21, 2015
    Date of Event
    July 19, 2015
    Report Date
    December 19, 2016
    Manufacturer
    MERCURY MEDICAL
    Product Code
    CAI
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    1024404-10-20-2015-001-C
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE T-PIECE NEONATAL PATIENT CIRCUIT KIT DEVICE IS MANUFACTURED BY MERCURY MEDICAL. THIS DEVICE WAS APPROVED FOR MARKET UNDER FDA 510K #K093913. SINCE ITS INTRODUCTION, A PROTECTIVE CAP WAS ADDED IN 2012 AT THE REQUEST OF THE CLINICAL MARKET TO AID IN PREVENTING CONTAMINANT COLLECTION. THIS FEATURE IS A STANDARD FEATURE ON MANY PREDICATE DEVICES AND IS TO BE REMOVED PRIOR TO USE. THIS DEVICE IS TO BE USED BY A TRAINED AND QUALIFIED CLINICIAN (I.E. PRESCRIPTION USE ONLY). THE CAP AND T-PIECE VALVES ARE MANUFACTURED TO BE STANDARD ISO 15MM FITTINGS. HOWEVER, THE MASK IS MADE OF A PLIABLE SILICONE MATERIAL. IF INAPPROPRIATELY AND FORCIBLY MANIPULATED, THE MASK MAY BE INADVERTENTLY INSERTED INTO THE T-PIECE CAP. AS A RESULT, THE DEVICE WOULD BE OCCLUDED RESULTING IN DEVICE FAILURE AND POTENTIAL PATIENT INJURY. IN ADDITION, THE CURRENT DIRECTIONS FOR USE (DFU) DO NOT PROVIDE A WARNING REGARDING THIS POTENTIAL ERROR. APPROXIMATELY (B)(4) UNITS HAVE BEEN SOLD TO DATE WITH THIS FEATURE. THERE HAVE ONLY BEEN THREE COMPLAINTS RECEIVED RELATED TO THE FAILURE TO REMOVE THE CAP PRIOR TO INSERTING A MASK ON THE T-PIECE. THIS REPRESENTS A (B)(4) FAILURE RATE. MERCURY MEDICAL HAS ENHANCED THE DEVICE BY ADDING "RIBS" TO THE PROTECTIVE CAP TO PREVENT ACCIDENTAL INSERTION OF A MASK INTO THE PORT. IN ADDITION, THE DFU HAS BEEN UPDATED TO INCLUDE A STATEMENT TO INFORM THE USER TO REMOVE THE PROTECTIVE CAP PRIOR TO TESTING/PATIENT USE. MERCURY MEDICAL HAS ALSO INITIATED A RECALL FOR THIS PRODUCT. THE RECALL INVOLVES A FIELD SAFETY NOTICE (FSN) BEING SENT TO ALL CUSTOMERS TO NOTIFY USERS OF THIS POTENTIAL HARM. IN ADDITION, THE RECALL ALSO INVOLVES SENDING CAUTION LABELS TO ALL CUSTOMERS FOR ATTACHMENT TO ALL AFFECTED PRODUCT CURRENTLY IN THEIR INVENTORY.

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE ACTUAL COMPLAINT DEVICE HAS NOT BEEN MADE AVAILABLE TO CAREFUSION FOR FURTHER EVALUATION. HOWEVER, PICTURES OF THE COMPLAINT DEVICE SETUP WERE PROVIDED. THE PICTURES AND REPORTED INFORMATION HAVE BEEN FORWARDED TO THE LEGAL MANUFACTURER FOR EVALUATION. A FOLLOW UP WILL BE SENT ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL IS BEING FILED DUE TO A RETROSPECTIVE REVIEW OF MDR SUBMISSIONS. CORRECTIONS AND ADDITIONAL INFORMATION HAS BEEN COMPLETED. (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED TO CAREFUSION VIA AN MHRA ADVERSE INCIDENT REPORT (INCIDENT NUMBER (B)(4)): ATTENDED DELIVERY IN THEATRE 18. NEOPUFF HAD BEEN SET UP WITH BUNG IN END OF CIRCUIT AND THEN MASK PLACED ON TOP. THIS MEANT THAT WHEN THE CIRCUIT WAS CHECKED IT APPEARED TO BE GIVING THE CORRECT PRESSURES BUT IN FACT NO AIR WAS BEING DELIVERED VIA THE MASK. BABY CAME OUT FLAT AND STAFF STARTED RESUSCITATION. UNABLE TO VENTILATE THE BABY AND AT 2MINUTES OF AGE STAFF PUT OUT A CRASH CALL AND DECIDED TO CHANGE TO A SMALLER MASK. AT THIS POINT STAFF REALISED THE BUNG WAS BLOCKING THE CIRCUIT, REMOVED IT AND CONTINUED TO RESUSCITATE THE BABY. THE BABY PINKED UP QUICKLY, STARTED BREATHING AND WAS FINE FROM ABOUT 3MIN30 OF AGE. HOWEVER THIS COULD EASILY HAPPEN AGAIN AS THIS BUNG IS MADE OF CLEAR PLASTIC AND IS NOT ROUTINELY CHECKED FOR. CONSEQUENCE: NEAR MISS. ACTION TAKEN (INCLUDES ANY ACTION BY PATIENT, CARER OR HEALTHCARE PROFESSIONAL OR BY THE MANUFACTURER OR SUPPLIER): NEONATAL LEAD CONSULTANT INFORMED. CONSULTANT OF THE WEEK INFORMED. DELIVERY SUITE MANAGER TO HIGHLIGHT STAFF OF THE POTENTIAL ISSUE WITH THIS PRODUCT SO AS TO ENSURE ADDITIONAL CARE IS TAKEN WHEN USING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    623929 NEONATAL PATIENT CIRCUIT KIT CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI MERCURY MEDICAL M1091335VS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O