BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY RENTAL PUMP WITHOUT CASE

    MDR report key: 12453000 · Received September 10, 2021

    Report

    Report Number
    1419937-2021-00076
    Event Type
    Injury
    Date Received
    September 10, 2021
    Date of Event
    August 23, 2021
    Manufacturer
    MEDELA AG
    Product Code
    OMP
    UDI-DI
    07612367015578
    PMA / PMN Number
    K080357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S DRESSING HAS BEEN CHANGED THREE TIMES IN THE LAST COUPLE OF DAYS. THE PATIENT REFUSED TO DO ANY TROUBLESHOOTING, STATES HIS WIFE IS A WOUND CARE SPECIALIST AND SHE HAS BEEN TREATING HIM AND HAS BEEN DOING HIS DRESSING CHANGES. HE STATED HE IS EXPERIENCING BRUISING AROUND THE WOUND AND MAY HAVE AN INFECTION. HE WILL BE GETTING A CULTURE TO HAVE TESTED. THE PATIENT WAS ADVISED TO CONTACT HIS DOCTOR TO LET THEM KNOW WHAT HE IS EXPERIENCING. APRIA WILL BE SENDING OUT A NEW PUMP. ON (B)(6) 2021, MELODY FROM APRIA CALLED AND SHE'S BEEN TRYING TO REPRODUCE THE ISSUE THE CUSTOMER WAS EXPERIENCING. THE CUSTOMER HAS BEEN ASKING FOR MULTIPLE UNITS. THEY ALLEGED THAT THE PATIENT MAY BE DROPPING THE PUMPS. A MEDELA CLINICIAN CONTACTED THE PATIENT ON (B)(6) 2021, THE PATIENT RECEIVED A NEW PUMP ON (B)(6) 2021 BUT IT WAS NOT PUT BACK ON THE PATIENT AS OF YET. THE PATIENT'S WIFE ALLEGED THAT THE WOUND WAS INFECTED AND THEY HAD A CULTURE DONE ON (B)(6) 2021 AND THEY WERE AWAITING THE RESULTS OF THE CULTURE. THE MEDELA CLINICIAN FOLLOWED UP WITH THE PATIENT ON (B)(6) 2021, THEY STILL WERE AWAITING THE CULTURE RESULTS BUT THE REPLACEMENT PUMP WAS WORKING AS EXPECTED. ON (B)(6) 2021, THE MEDELA CLINICIAN FOLLOWED UP WITH THE PATIENT AND SPOKE WITH HIS WIFE, SHE STATED THE NEW DEVICE IS WORKING AS EXPECTED. HE IS BEING TREATED WITH ORAL CEFTIN FOR KLEBSIELLA. SHE ALSO REPORTED THAT SHE SUSPECTS THAT HE MAY HAVE GOTTEN THE WOUND INFECTION FROM BEING IN THE DOCTOR'S OFFICE. SHE REPORTED THAT EVERY TIME THEY GO TO THE WOUND DOCTOR THEY HAVE EXTREMELY LONG WAIT TIMES. SHE STATED ALL IS WELL. MEDELA IS FILING THIS REPORT, WHICH IS CONSIDERED A SERIOUS INJURY AS IT REQUIRED MEDICAL ATTENTION (MEDICATION WAS PRESCRIBED).

    Description of Event or Problem · 1

    ON (B)(6) 2021, MEDELA LLC WAS MADE AWARE THAT THE PATIENT'S LIBERTY PUMP WAS NOT WORKING LIKE IT WAS SUPPOSED TO. THERE WAS A CONTAINER ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350011 LIBERTY RENTAL PUMP WITHOUT CASE NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP MEDELA AG 101037810 07612367015578

    Patients

    Seq Age Sex Outcome Treatment
    1 Other