BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER HT

    MDR report key: 4152231 · Received October 1, 2014

    Report

    Report Number
    3003793891-2014-00001
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    RAND S.R.L.
    Product Code
    LGZ
    PMA / PMN Number
    K120026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: THIS UNIT WAS SERVICED IN THE FIELD. THE UNIT WAS THEN VERIFIED/TESTED. NO REPAIR WAS NECESSARY. IN ADDITION TO SERVICING, THE DEVICE LOG WAS ANALYZED. BASED ON THE EVENT DESCRIPTION AND THE LOG DATA, THERE WAS NO EVIDENCE OF A SYSTEM MALFUNCTION. CONCLUSION: OUR INVESTIGATION THUS FAR INDICATES THAT THE LOW PR3 WAS LIKELY CAUSED BY AN OCCLUSION OF THE WITHDRAWAL CATHETER WHICH, IN TURN, MAY HAVE BEEN DUE TO A LIMITED VOLUME OF PERFUSATE IN THE CAVITY IN COMBINATION WITH A LESS THAN OPTIMAL CATHETER PLACEMENT. BASED ON THE ANALYSIS CONDUCTED THUS FAR, WE HAVE DETERMINED THAT THE DEVICE WAS OPERATING IN CONFORMANCE WITH ITS SPECIFICATIONS AND DID NOT MALFUNCTION. AN INVESTIGATION INTO THE INCIDENT IS ONGOING, AND WE WILL SUBMIT A SUPPLEMENTAL MDR UPON CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    (B)(6) REPORTED A COMPLAINT RELATING TO USE OF THE PERFORMER HT, A PERFUSION SYSTEMS INTENDED TO PROVIDE ISOLATED HYPERTHERMIC PERFUSION IN THE THORACIC OR PERITONEAL CAVITY BY MEANS OF EXTRA-CORPOREAL CIRCULATION OF WARMED, PHYSIOLOGICALLY COMPATIBLE STERILE SOLUTION, ACCORDING TO A PROTOCOL TO BE SELECTED BY THE PHYSICIAN. THE COMPLAINT STATED THAT, DURING USE OF THE DEVICE, PATIENT OUTLET PRESSURE (PR3) WAS LOW, CAUSING THE PUMP TO STOP WORKING. AFTER SWITCHING FLOW, AND RESTARTING THE MACHINE, CIRCULATION TO THE PATIENT WAS RESUMED. THE PATIENT SUFFERED NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610082 PERFORMER HT LGZ RAND S.R.L.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK