BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO NPWT DEVICE

    MDR report key: 3932699 · Received July 14, 2014

    Report

    Report Number
    3006760724-2014-00393
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 18, 2014
    Report Date
    March 5, 2015
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ACTIVE INVESTIGATION IN PROGRESS; RESULTS OF INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENT REPORT.

    Description of Event or Problem · 1

    FAILURE TO MAINTAIN VACUUM. AN ONCOLOGICAL PATIENT WAS REFERRED FOR TREATMENT WITH RENASYS GO BY THE ONCO-ORTHOPEDIC DEPARTMENT AT (B)(6). (B)(6) 2014: SHE WAS HOSPITALIZED FOLLOWING A FALL AND RELEASED WITH THE RECOMMENDATION TO CONTINUE THE VACUUM TREATMENT. ON (B)(6) 2014 A REPORT WAS RECEIVED FROM THE FAMILY OF THE WOMAN WHO WAS BEING TREATED AT HER HOME WITH THE VACUUM DEVICE THAT THE DEVICE IS NOT PERFORMING THE SUCTION FUNCTION AND THERE IS SOME BLEEDING AROUND THE BANDAGE. HER HUSBAND WAS INSTRUCTED BY TELEPHONE TO DISASSEMBLE THE DEVICE AND TO REMOVE THE BANDAGE FROM THE WOUND. HE WAS TOLD THAT IF THE BLEEDING INCREASES, HE SHOULD GO TO THE HOSPITAL. LATER, THE PATIENT¿S HUSBAND REPORTED THAT THE PATIENT FAINTED, THE BLEEDING INCREASED AND SHE BEGAN VOMITING. AT 17:01 ON THE SAME DAY, HER HUSBAND REPORTED THAT SHE DIED IN THE AMBULANCE ON THE WAY TO THE HOSPITAL. LATER IT BECAME APPARENT THAT SHE HAD FAINTED BEFORE BUT THE AMBULANCE WAS CANCELLED BECAUSE HER SITUATION HAD IMPROVED.

    Description of Event or Problem · 1

    FAILURE TO MAINTAIN VACUUM. AN ONCOLOGICAL PATIENT WAS REFERRED FOR TREATMENT WITH RENASYS GO BY THE ONCO-ORTHOPOEDIC DEPARTMENT AT (B)(6) HOSPITAL BY THE (B)(6) FUND. (B)(6) 2014: SHE WAS HOSPITALIZED FOLLOWING A FALL AND RELEASED WITH THE RECOMMENDATION TO CONTINUE THE VACUUM TREATMENT. ON (B)(6) 2014 A REPORT WAS RECEIVED FROM THE FAMILY OF THE WOMAN WHO WAS BEING TREATED AT HER HOME WITH THE VACUUM DEVICE THAT THE DEVICE IS NOT PERFORMING THE SUCTION FUNCTION AND THERE IS SOME BLEEDING AROUND THE BANDAGE. HER HUSBAND WAS INSTRUCTED BY TELEPHONE TO DISASSEMBLE THE DEVICE AND TO REMOVE THE BANDAGE FROM THE WOUND. HE WAS TOLD THAT IF THE BLEEDING INCREASES, HE SHOULD GO TO THE HOSPITAL. LATER, THE PATIENT'S HUSBAND REPORTED THAT THE PATIENT FAINTED, THE BLEEDING INCREASED AND SHE BEGAN VOMITING. AT 17:01 ON THE SAME DAY, HER HUSBAND REPORTED THAT SHE DIED IN THE AMBULANCE ON THE WAY TO THE HOSPITAL. LATER IT BECAME APPARENT THAT SHE HAD FAINTED BEFORE BUT THE AMBULANCE WAS CANCELLED BECAUSE HER SITUATION HAD IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409369 RENASYS GO NPWT DEVICE RENASYS GO NPWT DEVICE BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164 KGUA121107

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death