BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XCELA

    MDR report key: 19538272 · Received June 14, 2024

    Report

    Report Number
    3008737795-2024-00006
    Event Type
    Injury
    Date Received
    June 14, 2024
    Date of Event
    October 22, 2018
    Report Date
    December 22, 2025
    Manufacturer
    PFM MEDICAL CPP SA
    Product Code
    LJT
    PMA / PMN Number
    K073210
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER CONDUCTED A DOCUMENTARY REVIEW OF THE BATCHES SENT AND CONFIRMED THAT THE PRODUCTS MEET THEIR SPECIFICATIONS. THE COMPLAINT IS CLASSIFIED AS UNVERIFIABLE, AS THERE IS NO RETURN PRODUCT AND THE REFERENCE AND BATCH NUMBER ARE UNKNOWN. THIS RISK HAS BEEN IDENTIFIED IN OUR RISK ANALYSIS, AND ITS OCCURRENCE RATE IS BELOW THE DEFINED ACCEPTABLE FREQUENCY RATE. SUBJECT DEVICE EXPIRATION DATES AND GTIN NUMBERS FOR EACH LOT: (B)(6) LOT: 131899000 EXPIRATION DATE: 2018-12-30 GTIN NUMBER: 0764011098527. (B)(6) LOT: 132291000 EXPIRATION DATE: 2018-12-30 GTIN NUMBER: 0764011098525. (B)(6) LOT: 131889000 EXPIRATION DATE: 2018-12-30 GTIN NUMBER: 0764011098525. (B)(6) LOT: 131828000 EXPIRATION DATE: 2018-06-30 GTIN NUMBER: 0764011098527. (B)(6) LOT: 131539000 EXPIRATION DATE: 2018-06-30 GTIN NUMBER: 0764011098527. (B)(6) LOT: 131358000 EXPIRATION DATE: 2018-06-30 GTIN NUMBER: 0764011098527. (B)(6) LOT: 131355000 EXPIRATION DATE: 2018-06-30 GTIN NUMBER: 0764011098525. (B)(6) LOT: 130811000 EXPIRATION DATE: 2018-06-30 GTIN NUMBER: 0764011098525.

    Additional Manufacturer Narrative · 0

    UNABLE TO DETERMINE IF THE SUSPECT DEVICE WAS MANUFACTURED BY PFM DUE TO THE LACK OF PRODUCT INFORMATION. EVENT DETERMINED TO BE REPORTABLE AS A RESULT OF THE REMOVAL OF THE PORT DUE TO PATIENT INFECTION. UNABLE TO PERFORM A DHR REVIEW AS THE PRODUCT LOT INFORMATION IS REQUIRED. UNABLE TO DETERMINE IF THE PRODUCT WAS MANUFACTURED BY PFM. THERE HAS BEEN ONE OTHER COMPLAINT FOR REMOVAL OF THE PORT DUE TO PATIENT INFECTION IN THE USA WHICH OCCURRED IN 2022.

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT DUE TO DEVELOPING SEVERE SEPSIS. DURING PATIENT'S PROLONG HOSPITAL STAY, HE BECAME UNRESPONSIVE AND WAS FOUND TO HAVE A LARGE FRONTAL HEMORRHAGE. ON OR ABOUT (B)(6) 2018, PATIENT WAS INTUBATED. ON OR ABOUT (B)(6) 2018, PATIENT'S PORT WAS REMOVED BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6), KENTUCKY. ON OR ABOUT (B)(6) 2018, PATIENT SUFFERED A CARDIAC ARREST. ON OR ABOUT (B)(6) 2018, PATIENT UNDERWENT A TRACHEOSTOMY DUE TO THE INABILITY TO BE EXTUBATED WITHOUT EXPERIENCING RECURRENT RESPIRATORY FAILURE. PATIENT WAS DISCHARGED FROM (B)(6) HOSPITAL ON OR ABOUT (B)(6) 2018. ON OR ABOUT (B)(6) 2014, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PRODUCT AT THE (B)(6) HOSPITAL IN (B)(6), OHIO BY DR. (B)(6). THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2018, PATIENT PRESENTED HIMSELF TO (B)(6) HOSPITAL IN (B)(6), KENTUCKY WITH COMPLAINTS OF FEVER. UPON BEING ADMITTED, PATIENT'S BLOOD CULTURES WERE POSITIVE FOR INFECTION. PATIENT'S MEDICAL TEAM DETERMINED THAT THE PORT HAD TO BE REMOVED. ON OR ABOUT (B)(6) 2018, PATIENT'S PORT WAS REMOVED BY DR. (B)(6) AT (B)(6) HOSPITAL IN (B)(6) KENTUCKY.

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT DUE TO DEVELOPING SEVERE SEPSIS. DURING PATIENT'S PROLONG HOSPITAL STAY, HE BECAME UNRESPONSIVE AND WAS FOUND TO HAVE A LARGE FRONTAL HEMORRHAGE. ON OR ABOUT (B)(6) 2018, PATIENT WAS INTUBATED. ON OR ABOUT (B)(6) 2018, PATIENT'S PORT WAS REMOVED BY DR. (B)(6) AT ST. (B)(6) HOSPITAL IN EDGEWOOD, KENTUCKY. ON OR ABOUT (B)(6) 2018, PATIENT SUFFERED A CARDIAC ARREST. ON OR ABOUT (B)(6) 2018, PATIENT UNDERWENT A TRACHEOSTOMY DUE TO THE INABILITY TO BE EXTUBATED WITHOUT EXPERIENCING RECURRENT RESPIRATORY FAILURE. PATIENT WAS DISCHARGED FROM (B)(6) HOSPITAL ON OR ABOUT (B)(6) 2018. ON OR ABOUT (B)(6) 2014, PATIENT UNDERWENT PLACEMENT OF AN ANGIODYNAMICS XCELA PRODUCT AT THE (B)(6) HOSPITAL IN CINCINNATI, OHIO BY DR. (B)(6). THE DEVICE WAS IMPLANTED FOR THE PURPOSE OF ONGOING CHEMOTHERAPY. ON OR ABOUT (B)(6) 2018, PATIENT PRESENTED HIMSELF TO (B)(6) HOSPITAL IN EDGEWOOD, KENTUCKY WITH COMPLAINTS OF FEVER. UPON BEING ADMITTED, PATIENT'S BLOOD CULTURES WERE POSITIVE FOR INFECTION. PATIENT'S MEDICAL TEAM DETERMINED THAT THE PORT HAD TO BE REMOVED. ON OR ABOUT (B)(6) 2018, PATIENT'S PORT WAS REMOVED BY DR. (B)(6) AT (B)(6) HOSPITAL IN EDGEWOOD, KENTUCKY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372745 XCELA PORT LJT PFM MEDICAL CPP SA H965451030, H965451090 131899, 132291, 131828, 131539

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R