BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASOPRESS DIGITAL MINI PUMP

    MDR report key: 8945825 · Received August 29, 2019

    Report

    Report Number
    0001526350-2019-00729
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Report Date
    August 29, 2019
    Manufacturer
    ZIMMER SURGICAL, INC.
    Product Code
    JOW
    PMA / PMN Number
    K101915
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN RECORDED BY ZIMMER BIOMET UNDER (B)(4). THIS MEDWATCH IS BEING FILED TO RELAY CORRECTION INFORMATION. THERE WAS NO MALFUNCTION AND NO ASE, INFORMATION RECEIVED WAS ONLY FEEDBACK FROM THE CUSTOMER.

    Description of Event or Problem · 0

    THERE WAS NO MALFUNCTION AND NO ASE, INFORMATION RECEIVED WAS ONLY FEEDBACK FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    THIS EVENT IS RECORDED WITH ZIMMER BIOMET UNDER (B)(4). PRODUCT CODE: JOW. REPORTED ISSUE: ON (B)(6) 2019, IT WAS REPORTED THAT ''DURING STAFF TRAINING, A FACILITY IDENTIFIED THE POTENTIAL RISK OF TUBING MISCONNECTION BETWEEN GETINGE ATRIUM OASIS CHEST DRAINAGE AND COMPRESSION THERAPY PUMPS AND REPORTED THEIR FINDING TO ECRI INSTITUTE. SINCE THE CONNECTIONS ARE OF SIMILAR DESIGN AND SIZE, IT IS POSSIBLE TO CONNECT THE TUBING FROM THE VASOPRESS PUMP TO THE DRAINAGE TUBING COMING FROM THE PATIENT'S CHEST TUBE.'' DHR REVIEW: THE DEVICE HISTORY RECORD (DHR) AND PREVIOUS REPAIR HISTORY SEARCH FOR THE VP500DM VASOPRESS PUMP COULD NOT BE PERFORMED SINCE THE SERIAL # IS UNKNOWN AND NOT PROVIDED UPON REQUEST. COMPLAINT HISTORY REVIEW: ZIMMER BIOMET HAS RECEIVED NO REPORTS OF MISCONNECTION OR CROSS CONNECTION BETWEEN DEVICES NOR ITS ACCESSORIES (ATTACHMENT: GETINGE- ATRIUM CHEST DRAINS HAZARD REPORT). DEVICE EVALUATIONS RESULTS/INVESTIGATION FINDINGS: ON (B)(6) 2019, IT WAS REPORTED THAT ''DURING STAFF TRAINING, A FACILITY IDENTIFIED THE POTENTIAL RISK OF TUBING MISCONNECTION BETWEEN GETINGE ATRIUM OASIS CHEST DRAINAGE AND COMPRESSION THERAPY PUMPS AND REPORTED THEIR FINDING TO ECRI INSTITUTE. SINCE THE CONNECTIONS ARE OF SIMILAR DESIGN AND SIZE, IT IS POSSIBLE TO CONNECT THE TUBING FROM THE VASOPRESS PUMP TO THE DRAINAGE TUBING COMING FROM THE PATIENT'S CHEST TUBE.'' PRODUCT REVIEW OF THE VP500DM VASOPRESS PUMP WAS NOT PERFORMED BY ZIMMER BIOMET SURGICAL SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION TO ZIMMER BIOMET POST MARKET FOR EVALUATION AT THE TIME OF THIS INVESTIGATION. PER THE ATTACHMENT ''GETINGE- ATRIUM CHEST DRAINS HAZARD REPORT ''. ZIMMER BIOMET HAS RECEIVED NO REPORTS OF MISCONNECTION OR CROSS CONNECTION BETWEEN DEVICES NOR ITS ACCESSORIES. THE VASOPRESS IS NOT INTENDED FOR USE WITH DRAINAGE TUBING. THE VASOPRESS IS AN INTERMITTENT PNEUMATIC COMPRESSION SYSTEM THAT AIDS IN THE PREVENTION OF DEEP VEIN THROMBOSIS (DVT) AND IS ONLY INTENDED TO BE CONNECTED TO SOFT PLIABLE COMPRESSION GARMENTS FOR THE FOOT, CALF, OR THIGH. THE TUBING SET NECESSARY TO CONNECT THE VASOPRESS PUMP TO THE COMPRESSION GARMENT/SLEEVE HAS THE FOLLOWING FEATURES: IT IS AN OPAQUE DARK BLUE COLOR AND INCLUDES LARGE DURABLE TAGS DISPLAYING THE ZIMMER BIOMET LOGO. THE COLOR AND TAGS CAN REDUCE THE POTENTIAL FOR THE TUBING SET TO BE MISIDENTIFIED OR CONFUSED WITH TUBING SETS INTENDED FOR OTHER DEVICES. IT IS NON-DISPOSABLE AND ONCE CONNECTED TO THE VASOPRESS PUMP UPON INITIAL USE OR PLACEMENT, THE TUBING SET IS RARELY DISCONNECTED FROM THE PUMP. WHEN CHANGING THE COMPRESSION GARMENT/SLEEVE OR MOVING THE VASOPRESS PUMP TO ANOTHER LOCATION, THE TUBING SET IS COMMONLY DISCONNECTED AT THE GARMENT/SLEEVE END RATHER THAN AT THE VASOPRESS; THEREFORE, THE TUBING SET REMAINS CONNECTED TO THE PUMP. THIS PRACTICE LIMITS THE OPPORTUNITY FOR THE VASOPRESS CONNECTION POINTS TO BE AVAILABLE FOR INADVERTENT CONNECTION TO OTHER TUBING, SUCH AS CHEST DRAINAGE.'' PER THE IFU [VP500DM VASOPRESS SUPREME DVT MINI] UNDER SUGGESTIONS: ''THE PARTS AND/OR ACCESSORIES SUPPLIED ARE SPECIFICALLY DESIGNED FOR USE WITH VASOPRESSÒ SUPREME DVT MINI VP500DM CONTROL UNIT. USE OF OTHER PRODUCTS IN CONJUNCTION WITH THE SYSTEM IS NOT RECOMMENDED.'' PROBABLE CAUSE/ROOT CAUSE: THE REPORTED EVENT '' TUBING MISCONNECTION BETWEEN GETINGE ATRIUM OASIS CHEST DRAINAGE AND COMPRESSION THERAPY PUMPS'' WAS NOT CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION TO ZIMMER BIOMET POST MARKET FOR EVALUATION AT THE TIME OF THIS INVESTIGATION. A DEFINITIVE ROOT CAUSE OF THE TUBING MISCONNECTION COULD NOT BE DETERMINED WITH THE PROVIDED INFORMATION SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION TO ZIMMER BIOMET POST MARKET FOR EVALUATION AT THE TIME OF THIS INVESTIGATION AND THE IFU INDICATES, ''THE PARTS AND/OR ACCESSORIES SUPPLIED ARE SPECIFICALLY DESIGNED FOR USE WITH VASOPRESSÒ SUPREME DVT MINI VP500DM CONTROL UNIT.'' THE INVESTIGATION WAS BASED ON THE INFORMATION THAT WAS PROVIDED INITIALLY AND ANY INFORMATION THAT WAS OBTAINED THROUGHOUT THE FOLLOW-UP PROCESS. CONCLUSION: REVIEW OF THE INFORMATION PROVIDED DURING THE INVESTIGATION DETERMINED THERE IS NO FURTHER ACTIONS NEEDED AT THIS TIME (IE/CAPA/SCAR/HHE/D). THIS COMPLAINT WILL BE TRACKED AND TRENDED FOR ANY ADVERSE TRENDS THAT MAY WARRANT FURTHER ACTION.

    Description of Event or Problem · 1

    DURING STAFF TRAINING, A FACILITY IDENTIFIED THE POTENTIAL RISK OF TUBING MISCONNECTION BETWEEN GETINGE ATRIUM OASIS CHEST DRAINAGE AND COMPRESSION THERAPY PUMPS AND REPORTED THEIR FINDING TO ECRI INSTITUTE. SINCE THE CONNECTIONS ARE OF SIMILAR DESIGN AND SIZE, IT IS POSSIBLE TO CONNECT THE TUBING FROM THE VASOPRESS PUMP TO THE DRAINAGE TUBING COMING FROM THE PATIENT'S CHEST TUBE. NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741793 VASOPRESS DIGITAL MINI PUMP COMPRESSION THERAPY JOW ZIMMER SURGICAL, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1