BEUDAMED
    FDA Adverse Event Death Summary report: N

    TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 72-HOUR, 12 F, DSE

    MDR report key: 7530031 · Received May 21, 2018

    Report

    Report Number
    8030647-2018-00283
    Event Type
    Death
    Date Received
    May 21, 2018
    Report Date
    June 27, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, M7229T301, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. ALL INFORMATION REASONABLY KNOWN AS OF 16-MAY-2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED DATA- LOT NUMBER, EXPIRATION DATE, DEVICE MANUFACTURER DATE. HALYARD HEALTH RECEIVED ONE (1) USED SAMPLE THAT WAS NOT RETURNED WITH THE ORIGINAL PACKAGING. THE RETURNED DOUBLE SWIVEL ELBOW (DSE) AND FLEX CONNECTOR (MATING COMPONENT) WERE EXAMINED. THERE WERE NO VISIBLE DAMAGES TO THE MANIFOLD, MALE INSERT, OR FLEX CONNECTOR COMPONENTS. THE SAMPLE WAS EVALUATED AND CONFIRMED THE REPORTED FAILURE. THE ROOT CAUSE IS ATTRIBUTED TO A MANUFACTURING RELATED ISSUE. ALL INFORMATION REASONABLY KNOWN AS OF 17-JUL-2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENTS, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE THIRD OF THREE REPORTS. REFER TO 8030647-2018-00281 FOR THE FIRST EVENT. REFER TO 8030647-2018-00282 FOR THE SECOND EVENT. IT WAS REPORTED THAT THE FLEX CONNECTOR CAME AWAY FROM THE SUCTION CATHETER DURING A CHANGE OF THE PATIENT'S BODY POSITION. THE FLEX CONNECTOR'S USE WAS CONTINUED WITHOUT A REPLACEMENT FOR ANOTHER 24 HOURS. THE SUCTION CATHETER WAS REPLACED FOR A NEW AND THERE WAS NO PATIENT INJURY. HOWEVER, THE PATIENT PASSED AWAY AFTER THIS EVENT, BUT THERE WAS NO CAUSAL RELATIONSHIP BETWEEN THE SUCTION CATHETER DISCONNECTIONS AND THE PATIENT'S DEATH ACCORDING TO THE CHIEF NURSE OF THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372004 TURBO-CLEANING CLOSED SUCTION SYSTEM FOR ADULTS, 72-HOUR, 12 F, DSE VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY HALYARD HEALTH 22716-4J M7229T301

    Patients

    Seq Age Sex Outcome Treatment
    1 Death