BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP INVIA LIBERTY RESALE

    MDR report key: 7450125 · Received April 23, 2018

    Report

    Report Number
    1419937-2018-00108
    Event Type
    Injury
    Date Received
    April 23, 2018
    Date of Event
    March 14, 2018
    Report Date
    April 22, 2018
    Manufacturer
    MEDELA AG
    Product Code
    OMP
    PMA / PMN Number
    K142626
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED ON (B)(6)2018 BY MEDELA LLC AND WAS FORWARDED TO MEDELA AG (MANUFACTURER) IN SWITZERLAND ON (B)(6)2018. THE DEVICE WAS EVALUATED BY MEDELA AG. IN A REPORT DATED 08/21/2018, IT WAS NOTED THAT THE DEVICE PASSED VISUAL INSPECTION AND FUNCTIONAL CHECKS, WHICH INCLUDED PERFORMANCE WITHIN VACUUM SPECIFICATIONS. AS AN OBSERVATION, A REVIEW OF THE DEVICE'S LOG FILE DURING THE PERIOD OF (B)(6)2018 (START OF TREATMENT) AND (B)(6)2018 (END OF TREATMENT) INDICATED THAT THE DEVICE ALARMED REGARDING SYSTEM CLOG FOR A TOTAL OF 18 TIMES AND AIR LEAK FOR A TOTAL OF 31 TIMES, AND THE DEVICE WAS SWITCHED OFF FOR MULTIPLE HOURS ON FOUR SEPARATE OCCASIONS. ADDITIONALLY, THE SUPPLIER OF THE TRANSPARENT FILM/DRAPE REVIEWED THEIR BATCH RECORDS FOR THE DRESSING SET LOT NUMBER AND CONFIRMED THAT ADHESION TESTING PERFORMED ON THE FILM WAS WITHIN SPECIFICATION. THE CUSTOMER'S REPORT OF ADHESIVE ISSUES RELATED TO THE TRANSPARENT FILM AND SUCTION ISSUES RELATED TO THE DEVICE CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    ON 04/09/2018, THE DIRECTOR OF NURSING WAS CONTACTED FOR ADDITIONAL INFORMATION REGARDING THE REPORTED INCIDENT. SHE INDICATED THAT THE FACILITY PLACED THE LIBERTY DEVICE ON THE PATIENT ON (B)(6) 2018, AT WHICH POINT THE PATIENT'S WOUND MEASURED 4 CM X 5 CM. ON (B)(6) 2018 THE WOUND WAS NOTED TO HAVE AN ODOR AND EXUDATE AND WAS ENLARGED. SHE FELT THAT THE ISSUE APPEARED TO BE THAT THE TRANSPARENT FILM DID NOT ADHERE TO THE AREA AROUND THE WOUND (THERE WAS AN APPROXIMATE .25CM GAP), UNDER WHICH MOISTURE ACCUMULATED AND CAUSED WOUND MACERATION, LEADING TO AN INCREASED WOUND SIZE. SHE INDICATED THAT THE FIT PAD DIDN¿T STICK AS WELL, AND THE NURSING STAFF HAD TO USE EXTRA FILM TO SECURE THE FIT PAD. SHE INDICATED THAT THE ATTENDING DOCTOR FELT THAT THE PUMP DID NOT HAVE STRONG ENOUGH SUCTION, DESPITE THE FACT THAT THE SEALED WOUND MEASURED -125 MMHG OF VACUUM. THE PATIENT WAS REMOVED FROM THE DEVICE (THE WOUND MEASUREMENT WAS 5 CM X 6-1/2 CM) AND SHE WAS PLACED ON DAKINS SOLUTION WET TO DRY DRESSINGS AND ANTIBIOTICS TWICE A DAY FOR 10 DAYS STARTING ON (B)(6) 2018. ON 04/18/2018, FOLLOW UP REGARDING THE PATIENT STATUS WAS CONDUCTED WITH THE DIRECTOR OF NURSING, WHO INDICATED THAT THE PATIENT WAS PLACED ON A NON-MEDELA WOUND VAC ON (B)(6) 2018 PER PHYSICIAN ORDERS AND ON (B)(6) 2018, WOUND MEASUREMENTS WERE AT 3.8 CM X 3.5 CM X 1 CM. SHE ALSO INDICATED THAT THE PATIENT HAS AN INFECTIOUS DISEASE CONSULT IN (B)(6). THE DEVICE WAS RECEIVED ON 04/18/2018 AND EVALUATION IS PENDING AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE DIRECTOR OF NURSING FROM A FACILITY ALLEGED TO MEDELA LLC THAT WHILE USING THE LIBERTY NEGATIVE PRESSURE WOUND THERAPY PUMP WITH A MEDELA DRESSING SET, THE TRANSPARENT FILM DID NOT STICK TO THE PERI-WOUND, CAUSING THE PERI-WOUND TO MACERATE, WHICH RESULTED IN LARGER WOUND MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294435 PUMP INVIA LIBERTY RESALE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP MEDELA AG 0871000RC 17120022751 (DRESSING SET)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other