BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGPN,400X2-14,CB SAF,-,OQ,5

    MDR report key: 5686256 · Received May 27, 2016

    Report

    Report Number
    2026095-2016-00053
    Event Type
    Death
    Date Received
    May 27, 2016
    Report Date
    May 2, 2016
    Manufacturer
    HALYARD - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    PK063530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UDI # UNKNOWN. METHOD: THE ACTUAL DEVICE WAS NOT RETURNED. A LOT NUMBER WAS NOT PROVIDED AND REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS NOT PERFORMED. RESULTS: AS THE DEVICE WAS UNAVAILABLE FOR ANALYSIS, NO METHODS WERE PERFORMED. THEREFORE, RESULTS CANNOT BE OBTAINED. CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO (B)(4) FOR EVALUATION THEREFORE, WE ARE UNABLE TO DETERMINE THE CAUSE FOR THE REPORTED EVENT. (B)(4) HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE (B)(4) COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A (B)(4) PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    FILL VOLUME: UNKNOWN; FLOW RATE: UNKNOWN; PROCEDURE: UNKNOWN; CATHPLACE: INTERSCALENE BLOCK. A REPORT WAS RECEIVED STATING AN ANESTHESIOLOGIST NOTIFIED A COMPANY REPRESENTATIVE OF A DEATH THAT OCCURRED WITH A PATIENT ON POST-OP DAY ONE. THE PATIENT HAD AN ON-Q PUMP. THE ANESTHESIOLOGIST STATED THE PATIENT HAD A LOT OF CO-MORBIDITIES AND BELIEVED THAT THE ON-Q PUMP DID NOT HAVE ANYTHING TO DO WITH THE INCIDENT OF DEATH. ADDITIONAL INFORMATION RECEIVED ON 18-MAY-2016 STATED THE NURSE WAS PERFORMING A ROUTINE POST-OP FOLLOW-UP CALL TO THE PATIENT. THIS NURSE WAS NOTIFIED THAT THE PATIENT PASSED AWAY WHILE SLEEPING DURING THE NIGHT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340038 SURGPN,400X2-14,CB SAF,-,OQ,5 ELASTOMERIC - SAF MEB HALYARD - IRVINE K063530 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death