BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALINDROME

    MDR report key: 19861669 · Received July 30, 2024

    Report

    Report Number
    1282497-2024-00258
    Event Type
    Malfunction
    Date Received
    July 30, 2024
    Date of Event
    December 9, 2023
    Report Date
    July 30, 2024
    Manufacturer
    COVIDIEN LLC
    Product Code
    MSD
    PMA / PMN Number
    K111372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, A PATIENT WITH POLYCYSTIC KIDNEY DISEASE, HYPERTENSION, AND END-STAGE RENAL FAILURE. DURING ROUTINE HD (H EMODIALYSIS), THERE WAS 0.5-LITER FLUID LOSS AND MINIMAL HEPARIN. THE PATIENT WAS TAKEN OFF THE DIALYSIS MACHINE 30 MINUTES EARLIER DUE TO LOW TMP (TRANSMEMBRANE PRESSURE) AND BLOOD CLOT EVIDENCE IN THE ARTERIAL AND VENOUS CHAMBERS. THERE WAS AN INCREASE IN THE HEPARIN DOSAGE ADVISED FOR THE SUBSEQUENT DIALYSIS. FOR REFERENCE, MINIMAL HEPARIN IN THE UNIT WAS 1 ML (MILLILITER) BOLUS AND 1 ML PER HOUR (1000 UNITS PER ML). STANDARD CLEANING OF DIALYSIS CATHETERS WAS WITH GREEN CLINELL DEVICE WIPES, 2% CHLORHEXIDINE, 70% ALCOHOL, AND BD CHLORAPREP ON DRESSING CHANGE DAYS. THERE WAS NO REPORTED PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199751 PALINDROME CATHETER, HEMODIALYSIS, IMPLANTED MSD COVIDIEN LLC 8888145016 2234800152

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male