BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PICO 7

    MDR report key: 9837103 · Received March 16, 2020

    Report

    Report Number
    8043484-2020-00163
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 18, 2020
    Report Date
    April 7, 2020
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    OMP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE NOW CONCLUDED OUR INVESTIGATION FOR THE COMPLAINT RECEIVED. A REVIEW OF THE BATCH MANUFACTURING RECORDS COULD NOT BE PERFORMED AS NO PART OR LOT NUMBERS WERE PROVIDED, HOWEVER, THERE ARE NO INDICATIONS TO SUGGEST THAT THE DEVICE DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. A COMPLAINTS HISTORY REVIEW WAS CARRIED OUT ACROSS ALL PICO 7 PRODUCTS. THERE HAVE BEEN FURTHER COMPLAINTS REPORTED WITH THIS FAILURE MODE IN THE PAST THREE YEARS. THE DEVICE WAS USED FOR TREATMENT. IT WAS REPORTED THAT FOLLOWING TAKING A SHOWER THE DEVICE CONTINUED TO ALARM AND MAKE A BUZZING SOUND. AS THE DEVICE WAS NOT RETURNED A THOROUGH PRODUCT EVALUATION COULD NOT BE CARRIED OUT. IT IS POSSIBLE THAT WHEN THE DEVICE WAS REAPPLIED AFTER TAKING A SHOWER, THE CONNECTOR WAS NOT CORRECTLY FASTENED AND SECURED TO THE PUMP. IT IS ALSO POSSIBLE THAT THE DRESSING INTEGRITY MAY HAVE BEEN COMPROMISED IF IT CAME INTO DIRECT CONTACT WITH WATER. THE PUMP MONITORS THE LEVEL OF AIR LEAKS INTO THE DRESSING. IF THERE IS AN AIR LEAK ANYWHERE IN THE DRESSING, THE PUMP WILL MAKE SEVERAL ATTEMPTS TO REGAIN NEGATIVE PRESSURE (VACUUM) OVER A PERIOD OF TIME (THIS COULD RESULT IN A LOUDER THAN NORMAL BUZZING). IF IT DEEMS THAT THE LEAK IS TOO HIGH (I.E. IT WILL HAVE TO WORK TOO HARD TO MAINTAIN THE VACUUM), IT PAUSES THERAPY AND INDICATES THE LEAK TO THE USER SO THAT IT CAN BE RECTIFIED. WE HAVE NOT BEEN ABLE TO CONFIRM A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE OR DETERMINE A DEFINITIVE ROOT CAUSE. NO FURTHER ACTIONS BY SMITH AND NEPHEW ARE DEEMED NECESSARY AT THIS STAGE. HOWEVER, WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE. SMITH AND NEPHEW ACKNOWLEDGE CUSTOMER CONCERN AND ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED IN STATING THAT SHE RECEIVED A "ZIPLINE " INCISION CLOSURE AND A PICO DEVICE PLACED FOLLOWING SURGERY ON (B)(6) 2020. SHE WAS RELEASED FROM THE HOSPITAL ON (B)(6) FEB 2020. ON (B)(6) 2020, THE PATIENT SHOWERED AFTER DISCONNECTING THE UNIT FROM THE TUBING. THE PICO DEVICE HAS NOT WORKED SINCE. TODAY, THE DEVICE IS INDICATING THAT THERE IS AN AIR LEAK AND BY THE PATIENT'S ACCOUNT, "IT SCREAMS AT ME EVERY 5 HOURS". SHE DESCRIBES THE DEVICE AS BUZZING AND CARRYING ON. THE PATIENT IS NOTING MORE DRAINAGE ON THE DRAINAGE THAT IS YELLOW IN COLOR AND THAT THERE FEELS LIKE AN AREA IS SWOLLEN. THE PATIENT WAS INSTRUCTED PER CLINICAL GUIDELINES AND ENCOURAGED TO CONSULT WITH HER PROVIDER FOR FURTHER MEDICAL GUIDANCE. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298641 UNKNOWN PICO 7 NEGATIVE PRESSURE WOUND THERAPY POWERED SUCTION PUMP OMP SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1