BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENASYS GO RENTAL DEVICE

    MDR report key: 3651115 · Received February 27, 2014

    Report

    Report Number
    3006760724-2014-00024
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    February 5, 2014
    Report Date
    May 7, 2014
    Manufacturer
    SMITH & NEPHEW WOUND MANAGEMENT
    Product Code
    BTA
    PMA / PMN Number
    K083375
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ON 7 FEB 2014, SMITH & NEPHEW RECEIVED THE ABOVE REPORTED COMPLAINT FOR FAILURE TO ALARM. BASED ON THE INFORMATION PROVIDED, EXUDATE WAS OBSERVED AND IT IS NOT CLEAR IF THE EXUDATE ORIGINATED FROM THE RENASYS DRESSING OR THE DRESSING BELOW THE RENASYS DRESSING. THE DRESSING WAS REPORTEDLY COMPRESSED, SEALED AND EXUDATE TRAVELED THROUGH CANISTER TUBING INTO THE CANISTER. NO PATIENT INJURY REPORTED. THIS OCCURRENCE REPORTED MAY HAVE CAUSED A DISRUPTION IN PATIENT CARE, IT IS UNCLEAR IF THE DISRUPTION IN CARE IS DIRECTLY RELATED TO THE DEVICE OR PATIENTS HEALTH. RENASYS DRESSING APPLICATION SHOULD BE DONE IN ACCORDANCE WITH THE CLINICAL GUIDELINES. THE DEVICE (PUMP) WAS SENT TO THE SERVICE CENTER FOR FURTHER EVALUATION AND/OR REPAIRS IN TUTTLINGEN, GERMANY. BASED ON THE TECHNICIAN FINDINGS, NO ISSUES FOUND, UNABLE TO REPLICATE FAILURE REFERENCE RA# 203827-001, OCM14400201 REV. M. ALL RENASYS GO PUMP GO THROUGH A SERIES OF PERFORMANCE TESTS AND VISUAL CHECKS PRIOR TO RELEASE TO MARKET. HISTORICAL REVIEW OF PRIOR COMPLAINTS FOR LOT # KGUA120148 SHOWED NO PRIOR ISSUES. A DEVICE HISTORY RECORD REVIEW FOR LOT #KGUA120996 INDICATED THE LOT WAS MANUFACTURED IN ACCORDANCE WITH THE DEVICE MASTER RECORD. NO COMPLAINT REPORTED IN THE LAST 12 MONTHS, NOR HAS THE LOT HAS BEEN REPORTED IN ANOTHER COMPLAINT. SMITH & NEPHEW HAS ISSUED CAR02714 TO INITIATE RENASYS PRODUCT LABELING UPDATES. THESE LABELLING UPDATES WILL PROVIDE ENHANCED INFORMATION ON THE FUNCTIONALITY OF THE ALARMS AS THEY RELATE TO THE DESIGN OF THE DEVICE, AND SCENARIOS THAT CAN OCCUR IN CLINICAL SETTINGS WHICH MAY IMPACT ALARM FUNCTIONALITY.

    Description of Event or Problem · 1

    FAILURE TO ALARM DRESSING APPEARED TO HAVE LEAKED BUT DEVICE NOT ALARMING. REPORTED DELAY IN ALARM

    Description of Event or Problem · 1

    FAILURE TO ALARM DRESSING APPEARED TO HAVE LEAKED BUT DEVICE NOT ALARMING. REPORTED DELAY IN ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121987 RENASYS GO RENTAL DEVICE RENASYS GO RENTAL DEVICE BTA SMITH & NEPHEW WOUND MANAGEMENT 66800164

    Patients

    Seq Age Sex Outcome Treatment
    1