BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XCELA POWER INJECTABLE PORT

    MDR report key: 2613696 · Received May 14, 2012

    Report

    Report Number
    2032582-2012-00003
    Event Type
    Malfunction
    Date Received
    May 14, 2012
    Report Date
    May 10, 2012
    Manufacturer
    PFM MEDICAL, INC
    Product Code
    LJT
    PMA / PMN Number
    K073210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PFM MEDICAL RECEIVED THE COMPLAINT ON (B)(4) 2012. THE DHR WAS REVIEWED. THE RECORDS FOR LOT 102605 WERE COMPLETE AND IN ORDER. THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH LOT 102605. THE LABELING WAS REVIEWED. THE IFU HAS MULTIPLE WARNINGS TO FOLLOW STERILE TECHNIQUE SUCH AS: "STERILE CONDITIONS MUST BE MAINTAINED DURING THE IMPLANTATION PROCEDURE"; "STERILE CONDITIONS MUST BE MAINTAINED DURING THESE PROCEDURES"; "STERILE CONDITIONS MUST BE PREVAILED FOR ANY PUNCTURE PROCEDURE. THE STERILIZATION PROCESS WAS REVIEWED. LOT 102605 WAS STERILIZED UNDER STERILIZATION RUN 1120. THERE ARE NO NON-CONFORMANCES ASSOCIATED WITH THE STERILIZATION RUN 1120. THE PHYSICIAN ACCEPTANCE CRITERIA OF THE PRECONDITIONING, THE CYCLE AND THE DEGASSING WERE IN COMPLIANCE WITH THE VALIDATED SPECIFICATIONS OF THE STERILIZATION CYCLE. THE MICROBIOLOGICAL ACCEPTANCE CRITERIA OF THE CYCLE WERE IN COMPLIANCE WITH VALIDATED SPECIFICATIONS OF STERILIZATION CYCLE. PRODUCT BIOBURDEN WAS LESS THAN 9 CFU. LAL TESTING FOR THE LOT WAS WITHIN SPECIFICATION. THE BIOLOGICAL AND IN-PROCESS TESTING SHOWED THAT THE PRODUCT MET ALL SPECIFICATION AT RELEASE. NO SIMILAR COMPLAINT HAS BEEN RECORDED FOR LOT 102605 OR STERILIZATION LOT 1120. UNABLE TO CONFIRM THE NATURE OF THE COMPLAINT. ISOLATED INCIDENT. ACTUAL DEVICE NOT EVALUATED; ASSEMBLY AND PACKAGING REVIEW; STERILIZATION PROCESS REVIEW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED: "BSC FORWARDED MEDWATCH (B)(4) TO NAVILYST MEDICAL. EVENT DESCRIPTION IS: "PATIENT WENT TO SURGERY (B)(6) 2011, TO REMOVE A MALFUNCTIONING PORT-A-CATH THAT WAS PLACED IN (B)(6) 2011. THE SURGEON DOCUMENTED LEFT-SIDED PORT-A-CATH PLACED A (B)(6) AGO AND THE WOUND WAS NOT HEALED COMPLETELY GIVING RISE TO WHAT APPEARS TO BE CHRONIC PORT POCKET INFECTION. NOT FOR SURE IF THIS WAS MALFUNCTIONING PORT OR AN INFECTED PORT. SURGEON DOCUMENTED "NOT RESPONDING TO ANTIBIOTIC." WHAT WAS THE ORIGINAL INTENDED PROCEDURE? PREOP DX: MALFUNCTIONING PORT-A-CATH POST OP: MALFUNCTIONING PORT-A-CATH DEVICE USAGE PROBLEM: DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO." THE CUSTOMER DID NOT RETURN A SAMPLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XCELA POWER INJECTABLE PORT PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT PFM MEDICAL, INC H965451110 102605

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention