BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UL LIBERTY CYCLER

    MDR report key: 7348588 · Received March 19, 2018

    Report

    Report Number
    2937457-2018-00815
    Event Type
    Injury
    Date Received
    March 19, 2018
    Date of Event
    February 27, 2018
    Report Date
    April 6, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861100972
    PMA / PMN Number
    K123630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    DATA IS AS FOLLOWS: A PERITONEAL DIALYSIS REQUESTED ASSISTANCE FROM TECHNICAL SUPPORT DUE TO A SCALE PROBLEM ERROR THE PREVIOUS EVENING. THE PATIENT STATED SHE HAD BEEN RELEASED FROM THE HOSPITAL. UPON FOLLOW UP WITH THE PATIENT'S NURSE, IT WAS CONFIRMED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR PERITONITIS. THE SOURCE OF PERITONITIS AND THE HOSPITAL DISCHARGE SUMMARY WERE NOT AVAILABLE. CLINICAL EVALUATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN THE LIBERTY CYCLER/FMC CASSETTE AND THE PATIENT¿S (PT) HOSPITALIZATION FOR PERITONITIS. HOWEVER, THERE HAVE BEEN NO REPORTED ALLEGATIONS OR LIBERTY CYCLER/FMC CASSETTE MALFUNCTION THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE PT¿S PERITONITIS EVENT. DUE TO THE LACK OF INFORMATION, THE ETIOLOGY FOR THE PT¿S PERITONITIS EVENT CANNOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS CLINICAL INVESTIGATION WILL BE RE-EVALUATED ACCORDINGLY.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS REQUESTED ASSISTANCE FROM TECHNICAL SUPPORT DUE TO A SCALE PROBLEM ERROR THE PREVIOUS EVENING. THE PATIENT STATED SHE HAD BEEN RELEASED FROM THE HOSPITAL. UPON FOLLOW UP WITH THE PATIENT'S NURSE, IT WAS CONFIRMED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR PERITONITIS. THE SOURCE OF PERITONITIS AND THE HOSPITAL DISCHARGE SUMMARY WERE NOT AVAILABLE. ASSOCIATIONS ( 1 OBJECTS SELECTED ) ATTRIBUTES INFORMATION NAME: NUMBER: REPORTABLE DUE: C-217710 8000985889 10 DAY(S) LEFT COMPLAINT FILE OWNER: ENTERED BY: REHAN ANSARI WCADMIN, ADMINISTRATOR EVENT DETAILS REQUEST TYPE: FUNCTIONAL CHECKS COMPLETE: CYC N/A NOTIFIED DATE: EVENT DATE: (B)(6) 2018 00:00:00 EST (B)(6) 2018 00:00:00 EST INCIDENT ENTRY LOCATION: INCIDENT LOCATION: WALTHAM (CORPORATE) HOME EVENT SOURCE: MODE OF COMMUNICATION: PATIENT TELEPHONE COUNTRY OF INCIDENT: WHEN EVENT OCCURRED: UNITED STATES DURING PREP DID THE MACHINE ALARM/ALERT APPROPRIATELY DURING THE REPORTED EVENT?: DIALYSIS MODALITY: N/A PD EVENT DESCRIPTION: IS PV NOTIFIED: A PERITONEAL DIALYSIS REQUESTED ASSISTANCE FROM TECHNICAL SUPPORT DUE TO A SCALE PROBLEM ERROR THE PREVIOUS EVENING. THE PATIENT STATED SHE HAD BEEN RELEASED FROM THE HOSPITAL. UPON FOLLOW UP WITH THE PATIENT'S NURSE, IT WAS CONFIRMED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR PERITONITIS. THE SOURCE OF PERITONITIS AND THE HOSPITAL DISCHARGE SUMMARY WERE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. ALL DEVICE HISTORY RECORDS (DHR) ARE REVIEWED AND RELEASED ACCORDING TO THE DHR REVIEW CHECKLIST AND RELEASE PROCEDURE. A DEVICE IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. IN ADDITION, THE DEVICE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    C-217710 - (B)(4) (CREATION) ASSOCIATIONS ( 1 OBJECTS SELECTED ) ATTRIBUTES INFORMATION NAME: NUMBER: REPORTABLE DUE: C-217710 (B)(4) 10 DAY(S) LEFT COMPLAINT FILE OWNER: ENTERED BY: (B)(6) (B)(4) ADMIN, ADMINISTRATOR EVENT DETAILS REQUEST TYPE: FUNCTIONAL CHECKS COMPLETE: CYC N/A NOTIFIED DATE: EVENT DATE: (B)(6) 2018 00:00:00 EST (B)(6) 2018 00:00:00 EST INCIDENT ENTRY LOCATION: INCIDENT LOCATION: (B)(4) (CORPORATE) HOME EVENT SOURCE: MODE OF COMMUNICATION: PATIENT TELEPHONE COUNTRY OF INCIDENT: WHEN EVENT OCCURRED: UNITED STATES DURING PREP DID THE MACHINE ALARM/ALERT APPROPRIATELY DURING THE REPORTED EVENT?: DIALYSIS MODALITY: N/A PD EVENT DESCRIPTION: IS PV NOTIFIED: A PERITONEAL DIALYSIS REQUESTED ASSISTANCE FROM TECHNICAL SUPPORT DUE TO A SCALE PROBLEM ERROR THE PREVIOUS EVENING. THE PATIENT STATED SHE HAD BEEN RELEASED FROM THE HOSPITAL. UPON FOLLOW UP WITH THE PATIENT'S NURSE, IT WAS CONFIRMED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR PERITONITIS. THE SOURCE OF PERITONITIS AND THE HOSPITAL DISCHARGE SUMMARY WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191553 UL LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861100972

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization LIBERTY CYCLER SET| PD FLUID| LIBERTY CYCLER SET| PD FLUID