BEUDAMED
    FDA Adverse Event Death Summary report: N

    TITA JET LIGHT II HP PUR KIT F8

    MDR report key: 2381295 · Received December 15, 2011

    Report

    Report Number
    2032582-2010-00011
    Event Type
    Death
    Date Received
    December 15, 2011
    Date of Event
    November 15, 2011
    Report Date
    December 12, 2011
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DHR FOR LN 102541000 WAS COMPLETE AND IN ORDER. NO NON-CONFORMANCES HAVE BEEN RECORDED FOR THIS LN. LN 102541000 WAS STERILIZED BY ETO IN (B)(6) 2011. THE STERILIZATION LOT WAS 1108. THE RECORDS FOR RUN 1108 WERE COMPLETE AND IN ORDER. THE PHYSICAL ACCEPTANCE CRITERIA FOR THE PRECONDITIONING, MAIN CYCLE, AND THE DEGASSING WERE IN COMPLIANCE WITH VALIDATED SPECIFICATIONS. THE MICROBIOLOGICAL ACCEPTANCE CRITERIA OF THE CYCLE WERE IN COMPLIANCE WITH VALIDATED SPECIFICATIONS. A PRODUCT BIOBURDEN TEST WAS CONDUCTED AND SHOWED MICROBIOLOGICAL LEVELS WELL BELOW ACCEPTABLE LIMITS. AN INVESTIGATION OF THE RETURNED PORT WAS CONDUCTED. A FLUSH TEST WAS CONDUCTED AND THE FUNCTIONALITY OF THE PRODUCT WAS CONFIRMED. THE PORT WAS NOT OCCLUDED AND THERE WAS NO DIFFICULTY IN ACCESSING THE PORT SEPTUM. AN INSPECTION OF THE PORT SEPTUM REVEALED THAT THE PORT HAD BEEN ACCESSED REGULARLY (20+ TIMES) DURING THE USE OF THE DEVICE. AN "INFECTION" IS A KNOWN FAILURE MODE AND IS COVERED IN THE RISK ANALYSIS FOR THE DEVICE. A REVIEW OF THE IFU FOR THE DEVICE WAS CONDUCTED. THE IFU CLEARLY STATES "STERILE CONDITIONS MUST BE MAINTAINED. UNFORTUNATELY PFM IS UNABLE TO CONFIRM THE NATURE OF THIS COMPLAINT. PFM'S INVESTIGATION OF THE RETURNED PORT FOUND THE PORT TO BE WITHIN SPECIFICATION AND ALL RECORDS WERE COMPLETE AND IN ORDER. NO SIMILAR COMPLAINTS OF THIS NATURE HAVE BEEN RECORDED AT PFM. PFM HAS DETERMINED THIS TO BE AN ISOLATED INCIDENT AND NO CORRECTIVE ACTION IS PLANNED AT THIS TIME. NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: "PT. PRESENTED TO A NEIGHBORING HOSPITAL WITH COMPLAINTS OF DIFFUSE PAIN, DECREASED PO INTAKE. HE HAD BEEN UNDERGOING PALLIATIVE CHEMO WITH CARBOPLATIN & TAXOL. TREATMENT HAD BEEN STOPPED ONE WEEK PRIOR TO THIS ADMISSION DUE TO RECURRENT HOSPITAL ADMISSION WITH DEHYDRATION AND UTI'S. IT WAS DETERMINED HE HAD A UTI AND WAS BEING TREATED. WHEN IT WAS DISCOVERED, IT WAS UROSEPSIS HE WAS TRANSFERRED TO (B)(6) HOSPITAL. PT'S BLOOD CULTURES CONTINUED TO GROW (B)(6) DESPITE BEING ON VANCOMYCIN SINCE (B)(6) 2011. THE DECISION WAS MADE TO REMOVE THE PORT-A-CATH BECAUSE IT WAS THOUGH THIS WAS A SOURCE OF INFECTION. THE PORT-A-CATH WAS REMOVED UNDER LOCAL ANESTHESIA. WHEN THE SURGEON MADE THE INCISION NEAR THE PORT SITE, HE ENCOUNTERED A POCKET OF PURULENT MATERIAL WHICH WAS CULTURED. THE TIP OF THE CATHETER FROM NEARLY 5CM HAD A FIBRINOUS EXUDATE AS WELL AS CONTAINING INFLAMED LOOKING EXUDATE ACCORDING TO THE SURGEON'S OP NOTE. THE PT TOLERATED THE SURGICAL PROCEDURE WELL. THE PT HAD A RRT CALLED ON (B)(6) 2011 AND CT OF CHEST WAS DONE AND PT WAS TRANSFERRED TO ICU. PT INTUBATED AND MECHANICAL VENTILATION BUT DESPITE CPR ON (B)(6) 2011 THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITA JET LIGHT II HP PUR KIT F8 PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT PFM MEDICAL, INC 102541000

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death| H| L