BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEM PUMP

    MDR report key: 10949851 · Received December 4, 2020

    Report

    Report Number
    1418479-2020-00047
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Report Date
    October 13, 2021
    Manufacturer
    RICHARD WOLF GMBH
    Product Code
    HIF
    UDI-DI
    04055207056523
    PMA / PMN Number
    K000180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. FOLLOW-UP REPORT #2 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND CHANGED INFORMATION. RWMIC CONSIDERS THIS MDR/COMPLAINT OPEN. RWMIC WILL SUBMIT A FOLLOW UP REPORT AFTER THE DEVICE EVALUATION HAS BEEN COMPLETED AND/OR NEW INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    RICHARD WOLF MEDICAL INSTRUMENTS (MIC) IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. MIC IS THE IMPORTER OF THIS DEVICE. FOLLOW-UP REPORT #1 IS TO PROVIDE FDA WITH MISSING INFORMATION, NEW INFORMATION, AND CHANGED INFORMATION. CHANGED INFORMATION: THE DEVICE WAS NOT RETURNED TO MIC FOR INVESTIGATION. THE USER FACILITY WAS CONTACTED FOR ADDITIONAL INFORMATION HOWEVER THE USER FACILITY RESPONDED "NO FURTHER INFORMATION CAN BE PROVIDED". WITHOUT TESTING OR FURTHER INFORMATION FROM THE USER FACILITY, WE ARE UNABLE TO DETERMINE WHAT HAPPENED OR POSSIBLE CAUSES. REVIEWING THE IFU (GA-AS 001-USA) FOR WARNING AND CAUTIONS: CAUTION! DANGER OF FAULTS AND MALFUNCTIONS! TO GUARANTEE THE SAFETY OF THE USER, PATIENT AND OTHERS USE ONLY ACCESSORIES AND SPARE PARTS SPECIFIED BY THE MANUFACTURER OF THIS PRODUCT. OTHER ACCESSORIES OR SPARE PARTS CAN CAUSE THE EMISSION OF INCREASED ELECTROMAGNETIC RADIATION OR REDUCED IMMUNITY AGAINST INTERFERENCE. CAUTION! THE TEM PUMP MUST BE ENABLED TO PROPERLY PERFORM THE TEM PROCEDURES! IT IS POSSIBLE TO ENGAGE THE LAPAROSCOPIC INSUFFLATOR FUNCTION WHEN THE TEM CONFIGURATION IS DESIRED. WHEN PERFORMING TEM APPLICATIONS BE SURE THAT THE PUMP INDICATOR IS ILLUMINATED. IF THE PUMP IS NOT ENABLED, THE INSUFFLATOR WILL CYCLE BETWEEN ITS INSUFFLATION AND MEASUREMENT PERIODS. THIS CAN BE DETECTED BY A VISUAL PULSING OF THE GAS FLOW INDICATOR AND AN AUDIBLE PAUSE IN THE INSUFFLATION MODE. IF THIS SITUATION IS DETECTED, CHANGE THE MODE AS WRITTEN IN SECTION 4.8.2. CHECK ALL CONNECTIONS AND ASSURE THAT THE PUMP IS ENABLED. NOTES! FOR THE INSTRUMENTS MARKED " * " WE RECOMMEND THAT YOU ALWAYS HAVE A SPARE (BACKUP) UNIT AVAILABLE TO ENSURE IMMEDIATE ADEQUATE REPLACEMENT IN CASE OF SUDDEN FAILURE SO THAT THE OPERATION CAN BE COMPLETED IN DUE COURSE. RWMIC CONSIDERS THIS MDR CLOSED. IF WE RECEIVE ADDITIONAL INFORMATION ABOUT THIS DEVICE, A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF GMBH. RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. FOLLOW-UP REPORT #3 IS TO PROVIDE FDA WITH THE RESULTS OF THE DEVICE INVESTIGATION AND ANY NEW INFORMATION, AND CHANGED INFORMATION SINCE LAST SUBMISSION. RWMIC CONSIDERS THIS MDR CLOSED. RWMIC WILL SUBMIT A FOLLOW UP REPORT IF NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    WHEN THIS MDR WAS ORIGINALLY REPORTED, THE USER FACILITY GAVE US THE WRONG PART AND SERIAL NUMBER. RICHARD WOLF RECEIVED THE DEVICE IN FOR REPAIR AND DISCOVERED THE DISCREPANCY. THIS REPORT IS TO PROVIDE FDA WITH CORRECTED INFORMATION.

    Description of Event or Problem · 0

    THE PURPOSE OF THIS REPORT IS TO SHARE THE RESULTS OF THE DEVICE INVESTIGATION. RWMIC RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS VISUALLY, FUNCTIONALLY AND MECHANICALLY EVALUATED. THE REPORTED CONDITION WAS CONFIRMED. THE INVESTIGATION REPORT: "ACCORDING TO THE INSPECTION OF THE TEM-PUMP, THE BUSHINGS OF THE DEVICE HAVE STRONG SIGNS OF USE. THE ROLLER PUMP IS DEFECTIVE. THE ROLLER WHEEL NO LONGER ROTATES, THE GEAR FROM THE GEAR TOOTH HAS SHEARED OFF. THE CUSTOMER HAS EITHER INSERTED ANOTHER TUBE OR BLOCKED THE PUMP WHEEL. ACCORDING TO SAP, THE DEVICE WAS SENT BACK ONLY ONCE SINCE THE FIRST DELIVERY IN 2007, THE INVESTIGATION IN 2016 HAS NOT FOUND ANY PROBLEM OF THE DEVICE. THE USER IS INFORMED IN THE IFU GA-AS001/EN/2018-10 V12.0/PK18-9277 ABOUT PRODUCT COMBINATION AS WELL AS ABOUT REGULAR MAINTENANCE OF THE DEVICE. IF THESE ACTIONS WOULD HAVE BEEN TAKEN, THE PROBLEM WOULD NOT HAVE OCCURRED."

    Additional Manufacturer Narrative · 1

    RWMIC IS SUBMITTING THIS REPORT ON BEHALF OF RICHARD WOLF (B)(4). RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION IS THE IMPORTER OF THIS DEVICE. RWMIC CONSIDERS THIS MDR/COMPLAINT OPEN. RWMIC WILL SUBMIT A FOLLOW UP REPORT AFTER THE DEVICE EVALUATION HAS BEEN COMPLETED AND/OR NEW INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE USER FACILITY REPORTED THE FOLLOWING TO RICHARD WOLF MEDICAL INSTRUMENTS CORPORATION (RWMIC): THE UNIT STOPPED FUNCTIONING IN THE MIDDLE OF A PROCEDURE. THERE WAS NO PATIENT OF STAFF INJURY. MACHINE HAD A MECHANICAL ERROR AND COULD NOT GET IT TO FUNCTION. WILL THE DEVICE BE RETURNED? YES. WAS THE DEVICE BEING USED DURING A PROCEDURE WHEN THE ISSUE OCCURRED? YES. WAS THERE ANY INJURY OR ILLNESS TO THE PATIENT DUE TO THE REPORTED ISSUE? NO. WAS THERE ANY INJURY OR ILLNESS TO ANY OTHER PERSONNEL DUE TO THE REPORTED ISSUE? NO. DID THE ISSUE CAUSE A DELAY IN THE PROCEDURE BEING PERFORMED? YES. DID THE DELAY PUT THE PATIENT AT RISK? (ONLY APPLICABLE IF THERE WAS A REPORT OF DELAY) NO. WAS THERE A SIMILAR BACK-UP DEVICE AVAILABLE FOR USE? NO WAS THE SCHEDULED PROCEDURE COMPLETED? YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1412326 TEM PUMP TEM PUMP HIF RICHARD WOLF GMBH 2232644 04055207056523

    Patients

    Seq Age Sex Outcome Treatment
    1