BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA POWER INJECTABLE PLASTIC PORT

    MDR report key: 2906879 · Received January 4, 2013

    Report

    Report Number
    2032582-2012-00016
    Event Type
    Malfunction
    Date Received
    January 4, 2013
    Date of Event
    November 3, 2012
    Report Date
    December 17, 2012
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K072481
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REVIEWS WERE CONDUCTED AND THE FOLLOWING RESULTS WERE FOUND. INVENTORY IMPACT: ALL 250 PIECES FROM LOT NUMBER 120145 000 HAVE BEEN DELIVERED BETWEEN (B)(4) 2012. THERE ARE NO MORE PIECES FROM THIS LOT IN STOCK AT PFM MEDICAL. NO SIMILAR COMPLAINTS HAVE BEEN RECORDED FOR LOT NUMBER 120145000. NO SIMILAR COMPLAINTS FOR STERILIZATION WEEK (B)(4) 2009 WERE REPORTED. FOUR (4) SIMILAR COMPLAINTS WERE REPORTED WITHIN THE LAST THREE (3) YEARS. INVESTIGATIONS FOR ABOVE COMPLAINTS DID NOT CONCLUDE THAT THE VASCULAR ACCESS PORT SYSTEM WAS THE SOURCE OF REPORTED INFECTIONS. THE RISK OF INFECTION IS IDENTIFIED IN THE RISK ANALYSIS WITH AN ESTIMATED LOW OCCURRENCE RATE. GENERAL INSTRUCTIONS FOR ACCESSING THE PORT IS PROVIDED ON PAGE 11 OF THE IFU. "STERILE CONDITIONS MUST BE MAINTAINED FOR THESE PROCEDURES" IS INCLUDED IN THE IFU AND "STERILE CONDITIONS MUST BE PREVAILED FOR ANY PUNCTURE PROCEDURE" IS ALSO REPEATED. A DHR REVIEW INDICATES THAT THE RECORDS ARE COMPLETE AND IN ORDER FOR LOT NUMBER 120145000. THERE ARE NO NON-CONFORMITIES ASSOCIATED WITH THIS LOT. LOT NUMBER 120145 000 WAS STERILIZED BY (B)(4)2012. A QUANTITATIVE DETECTION OF BIOBURDEN ACCORDING TO EN/ISO 11737 IS COMPLETED ONCE A MONTH. THIS BIOBURDEN DETECTION FOR THE MONTH OF (B)(4) 2012, SHOWED MICROBIOLOGICAL CONTAMINATION WELL BELOW THE ACCEPTABLE MICROBIOLOGICAL CONTAMINATION FOR THE STERILIZATION CYCLE. THERE ARE NO NON-CONFORMITIES ASSOCIATED WITH THE CYCLE OF THE STERILIZATION FOR THE WEEK OF (B)(4) 2009. THE PHYSICAL ACCEPTANCE CRITERIA OF THE PRECONDITIONING, THE CYCLE AND THE DEGREASING WERE IN COMPLIANCE WITH THE VALIDATED SPECIFICATIONS OF THE STERILIZATION CYCLE. THE MICROBIOLOGICAL ACCEPTANCE CRITERIA OF THE CYCLE WERE IN COMPLIANCE WITH THE VALIDATED SPECIFICATIONS OF STERILIZATION CYCLE. WITHOUT THE RETURNED PRODUCT, PFM WAS UNABLE TO TEST AND SEE IF THERE WAS ACTUAL MALFUNCTION OF THE SYSTEM AND/OR WHAT SPECIFIC MALFUNCTION HAD OCCURRED. NO SAMPLE HAD BEEN RETURNED TO DATE. HOWEVER, IF THE SAMPLE IS RECEIVED AT A LATER DATE, THE COMPLAINT WILL BE REOPENED AND A FUNCTIONALITY TEST FOR THE PORT WILL BE CONDUCTED. A BIOLOGICAL ASSESSMENT WAS CONDUCTED AND IN-PROCESS TESTING ACTIVITIES SHOWED THAT THE PRODUCT WAS SAFE WHEN IT LEFT PFM MEDICAL. THE STERILIZATION CERTIFICATE AND THE LABORATORY TEST RESULTS ARE AVAILABLE FOR THIS COMPLAINT. PFM WILL CONTINUE TO MONITOR FOR THESE TYPES OF COMPLAINTS IN THE FUTURE. MFR EVAL, METHODS: REVIEWING ALL LABELING (INCLUDING INSTRUCTIONS FOR USE, MANUALS, AND PACKAGING) FOR LANGUAGE RELATED TO REPORTED DEVICE PROBLEMS. PERFORMING A REVIEW OF THE MFG AND PRODUCTION PROCESSES AND/OR RECORDS FOR A SPECIFIC DEVICE OR LOT THAT MAY HAVE CONTRIBUTED TO PROBLEMS WITH A DEVICE. PERFORMING A REVIEW OF THE RECORDS AND PROCESSES USED TO RENDER A PRODUCT FREE FROM VIABLE MICROORGANISMS. VERIFYING THAT THE METHODS USED TO FREE A MEDICAL DEVICE FROM VIABLE MICROORGANISMS SUCH AS FUNGI, BACTERIA, AND VIRUSES WERE FOLLOWED. RESULTS: DEVICE NOT RETURNED. THE DEVICE EITHER FUNCTIONED AS DESIGNED OR A FAILURE WAS NOT FOUND. CONCLUSION: THE DEVICE COMPLAINT OR PROBLEM CANNOT BE CONFIRMED. IF POSSIBLE, CHOOSE A MORE SPECIFIC REASON AMONG THE TERMS LISTED IN THIS BRANCH OF THE HIERARCHY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT S/HE "RECEIVED A PHONE CALL FROM THE MOTHER OF A PEDIATRIC PT WHO HAD XCELA PORT ((B)(4), LOT NUMBER 120145 000) IN PLACE IN THE LEFT CHEST FOR CHEMOTHERAPY TREATMENT. THE PORT WAS PLACED ON (B)(6) 2012. THE PORT WAS REMOVED ON SATURDAY, (B)(6) 2012, DUE TO IT NOT WORKING; PAIN AND SWELLING AT PORT SITE WITH NO BLOOD RETURN. ADDITIONAL INFORMATION: "THE PT IS UNDERGOING CHEMOTHERAPY TREATMENT. A NEW PORT WAS NOT PLACED DUE TO CONCERN OF INFECTION. THE PORT SITE WAS LEFT AS AN OPEN WOUND SO THAT IT COULD FILL OVER TIME ALLOWING FOR SUTURES AT A LATER DATE. TREATMENT HAS BEEN SUSPENDED AT THIS TIME."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5517 XCELA POWER INJECTABLE PLASTIC PORT XCELA PORT LJT PFM MEDICAL, INC 120145 000

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention