BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLO II OR PRISMAFLO IIS

    MDR report key: 8342353 · Received February 15, 2019

    Report

    Report Number
    9617473-2018-00003
    Event Type
    Malfunction
    Date Received
    February 15, 2019
    Manufacturer
    STIHLER ELECTRONIC GMBH
    Product Code
    KOC
    PMA / PMN Number
    K082758
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATIONS ARE NOT POSSIBLE AS THE DEFECTIVE HEATING PROFILE WAS NOT AVAILABLE FOR INVESTIGATION AND S/N OF DEFECTIVE HEATING PROFILE WAS NOT TRANSMITTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENT REPORT WILL BE SUBMITTED. BECAUSE OF THE CHARACTERISTICS OF THIS EVENT THE MANUFACTURER JUDGES THAT THIS EVENT FITS IN THE RECALL OF THIS PRODUCT THAT ADDRESSES THE POTENTIAL FAILURE. THE INDICATION THAT PCA WAS "SAPPED" IS NOT POSSIBLE AS THE APPLIED PART OF PRODUCT IS CLASSIFIED "CF". AS SOON AS THE HEALTHCARE PROVIDER RESPONDS TO THE "URGENT MEDICAL DEVICE CORRECTION" FORM FROM STIHLER ELECTRONIC THE AFFECTED HEATING PROFILE WILL BE REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CONTINOUS RENAL REPLACEMENT THERAPY (CRRT) USING A BLOOD WARMER (PRSIMAFLO II OR PRISMAFLO IIS). THE USER NOTICED A SMALL BUBBLE ON THE SURFACE OF THE HEATING PROFILE. THE BUBBLE WAS GLOWING RED AND ISSUING A SMALL AMOUNT OF SMOKE. TREATMENT WAS DISCONTINUED. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139294 PRISMAFLO II OR PRISMAFLO IIS BLOOD WARMER KOC STIHLER ELECTRONIC GMBH NO INFORMATION

    Patients

    Seq Age Sex Outcome Treatment
    1