BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE PATIENT CONN

    MDR report key: 17715830 · Received September 8, 2023

    Report

    Report Number
    0008030665-2023-00852
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    August 31, 2023
    Report Date
    November 22, 2023
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861100743
    PMA / PMN Number
    K173718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, A PHYSICAL EVALUATION COULD NOT BE PERFORMED. A BATCH RECORDS REVIEW WAS CONDUCTED BY THE MANUFACTURER FOR THE REPORTED LOT. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. IN ADDITION, A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE LOT MET ALL SPECIFICATIONS FOR RELEASE. A PRODUCT HISTORY REVIEW DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 0

    A LICENSED PRACTICAL NURSE (LPN) FROM A LONG-TERM CARE (LTC) FACILITY REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A FLUID LEAK OCCURRED DURING A PATIENT'S PERITONEAL DIALYSIS (PD) TREATMENT. PRIOR TO DISCOVERY OF THE FLUID LEAK, IT WAS REPORTED THAT AN ¿M31 AIR DETECTED IN CASSETTE¿ ALARM OCCURRED DURING DRAIN 3 OF 6. THE LPN CONTACTED TS FOR ASSISTANCE IN BYPASSING THE ALARM. AFTER FAILING TO MOVE PAST THE ALARM, THE LPN WAS ADVISED TO RESETUP THE CYCLER WITH NEW SUPPLIES. WHEN THE LPN OPENED THE CYCLER DOOR, THE FLUID LEAK WAS DISCOVERED. THE LPN CONFIRMED THERE WAS NO VISIBLE DAMAGE ON THE BACK OF THE CASSETTE. THE ORIGIN OF THE LEAK WAS NOT KNOWN. THE PATIENT DID NOT COMPLETE THEIR TREATMENT. THE LPN SAID THE STAFF AT THE FACILITY WERE NEVER TRAINED TO PERFORM MANUAL PD EXCHANGES AS AN ALTERNATIVE TO USING THE CYCLER. THE LPN WAS ADVISED BY TS TO LET THE CYCLER DRY OUT AND WAIT A FULL 24-HOURS BEFORE USING IT AGAIN. IN ORDER TO DO THIS, THE PATIENT HAD TO MISS TREATMENT THE FOLLOWING DAY AS WELL. HOWEVER, THE LPN CONFIRMED THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, EXPERIENCE ANY ADVERSE EFFECTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE LPN CONFIRMED THE PATIENT¿S DOCTOR WAS NOTIFIED, AND PROPHYLACTIC ANTIBIOTICS WERE NOT PRESCRIBED. THE PATIENT WAS SAID TO BE CONTINUING PD THERAPY ON THE SAME CYCLER WITHOUT ANY FURTHER ISSUES. THE CYCLER SET WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION AS IT HAD BEEN DISCARDED.

    Description of Event or Problem · 0

    A LICENSED PRACTICAL NURSE (LPN) FROM A LONG-TERM CARE (LTC) FACILITY REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A FLUID LEAK OCCURRED DURING A PATIENT'S PERITONEAL DIALYSIS (PD) TREATMENT. PRIOR TO DISCOVERY OF THE FLUID LEAK, IT WAS REPORTED THAT AN ¿M31 AIR DETECTED IN CASSETTE¿ ALARM OCCURRED DURING DRAIN 3 OF 6. THE LPN CONTACTED TS FOR ASSISTANCE IN BYPASSING THE ALARM. AFTER FAILING TO MOVE PAST THE ALARM, THE LPN WAS ADVISED TO RESETUP THE CYCLER WITH NEW SUPPLIES. WHEN THE LPN OPENED THE CYCLER DOOR, THE FLUID LEAK WAS DISCOVERED. THE LPN CONFIRMED THERE WAS NO VISIBLE DAMAGE ON THE BACK OF THE CASSETTE. THE ORIGIN OF THE LEAK WAS NOT KNOWN. THE PATIENT DID NOT COMPLETE THEIR TREATMENT. THE LPN SAID THE STAFF AT THE FACILITY WERE NEVER TRAINED TO PERFORM MANUAL PD EXCHANGES AS AN ALTERNATIVE TO USING THE CYCLER. THE LPN WAS ADVISED BY TS TO LET THE CYCLER DRY OUT AND WAIT A FULL 24-HOURS BEFORE USING IT AGAIN. IN ORDER TO DO THIS, THE PATIENT HAD TO MISS TREATMENT THE FOLLOWING DAY AS WELL. HOWEVER, THE LPN CONFIRMED THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, EXPERIENCE ANY ADVERSE EFFECTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE LPN CONFIRMED THE PATIENT¿S DOCTOR WAS NOTIFIED, AND PROPHYLACTIC ANTIBIOTICS WERE NOT PRESCRIBED. THE PATIENT WAS SAID TO BE CONTINUING PD THERAPY ON THE SAME CYCLER WITHOUT ANY FURTHER ISSUES. THE CYCLER SET WAS NOT AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION AS IT HAD BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1113696 LIBERTY CYCLER SET, SINGLE PATIENT CONN SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 22LR08065 00840861100743

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female DELFLEX PD FLUID.| DELFLEX PD FLUID.| LIBERTY SELECT CYCLER.| LIBERTY SELECT CYCLER.