BEUDAMED
    FDA Adverse Event Injury Summary report: N

    T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE

    MDR report key: 5110702 · Received September 29, 2015

    Report

    Report Number
    2050001-2015-00025
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    September 7, 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

    CFN-2015-5871. TO DATE THE ACTUAL COMPLAINT DEVICE HAS NOT BEEN MADE AVAILABLE TO CAREFUSION FOR FURTHER EVALUATION. A FOLLOW UP MDR WILL BE SENT ONCE THE INVESTIGATION IS COMPLETE.

    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

    THIS PRODUCT IS MANUFACTURED FOR CAREFUSION BY MERCURY MEDICAL. MERCURY MEDICAL IS THE LEGAL MANUFACTURER OF THE DEVICE. CAREFUSION DOES NOT OWN THE DESIGN, SPECIFICATIONS, OR REGULATORY PATHWAY FOR THE DEVICE. THE DEVICE IS LABELED AS A CAREFUSION PRODUCT AND IS SOLD AND MARKETED BY CAREFUSION.

    Description of Event or Problem · 1

    THE FOLLOWING WAS INITIALLY REPORTED TO CAREFUSION: "CAP PLACED ON CIRCUIT THEN FACEMASK ATTACHED, FLOW WAS NOT DELIVERED TO NEONATE. NEONATE BECAME HYPOXIC AND HAD BRAIN INJURY." ADDITIONAL INFORMATION WAS OBTAINED REGARDING THE EVENT. THE CAP ON THE VITAL SIGNS T PIECE WAS PLACED ONTO THE CIRCUIT THEN THE FACEMASK WAS FITTED. THIS OCCLUDED THE CIRCUIT AND STOPPED THE OXYGEN BEING DELIVERED TO THE NEONATE. NEONATE BECAME HYPOXIC AND HAD BRAIN INJURY. THE TRUST MEDICAL DIRECTOR HAS REPORTED THIS INCIDENT TO THE MHRA. IT WAS INDICATED THAT SAMPLES ARE AVAILABLE AND ARE CURRENTLY WITH THE END USER. THE CUSTOMER WAS ASKED TO CONFIRM IF THERE WAS A BRAIN INJURY TO THE NEONATE AS A RESULT OF THE HYPOXIA CONDITION. THE CUSTOMER INDICATED THAT THE PATIENT HAS GONE HOME AND THEY DID NOT KNOW THE LONG TERM EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641838 T-PIECE NEONATAL PATIENT CIRCUIT KIT, DISPOSABLE, WITH SIZE CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE) CAI MERCURY MEDICAL M1091316VS 14252

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| S