BEUDAMED
    FDA Adverse Event Death Summary report: N

    WALKMED® 350VL AMBULATORY INFUSION PUMP

    MDR report key: 22907469 · Received August 27, 2025

    Report

    Report Number
    3000204189-2025-00001
    Event Type
    Death
    Date Received
    August 27, 2025
    Date of Event
    July 3, 2025
    Report Date
    July 22, 2025
    Manufacturer
    WALKMED TECHNOLOGIES, LLC
    Product Code
    FRN
    UDI-DI
    00859695006077
    PMA / PMN Number
    K991275
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    WALKMED EVALUATED THE RETURNED 350VL INFUSION PUMP (SN (B)(6)) UNDER RGA #(B)(4) IN RESPONSE TO A REPORTED PATIENT DEATH. THE DEVICE UNDERWENT A FULL VISUAL AND FUNCTIONAL EVALUATION IN ACCORDANCE WITH SOP 100-700 AND FORM 100-601F6. THE PUMP FAILED PRESSURE PROFILE TESTING DUE TO CLAMP BAR MISALIGNMENT AND OUT-OF-SPEC PRESSURE PERFORMANCE. THIS CONDITION COULD RESULT IN IMPROPER OCCLUSION DETECTION OR ALTERED INFUSION ACCURACY, POTENTIALLY DELAYING THERAPY. NO OBSERVABLE PHYSICAL DAMAGE OR CONTAMINATION WAS FOUND. ALL OTHER FUNCTIONAL CHECKS PASSED. NOTABLY, THE DEVICE WAS ORIGINALLY MANUFACTURED AND RELEASED IN 2015, AND REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED FULL CONFORMANCE TO MANUFACTURING AND QUALITY RELEASE REQUIREMENTS AT THAT TIME. NO PRODUCTION DEVIATIONS OR NON-CONFORMANCES WERE NOTED. BASED ON THE SERVICE TECHNICIAN'S ASSESSMENT AND THE AGE OF THE DEVICE, THE CLAMP BAR MISALIGNMENT AND PRESSURE PROFILE DEVIATION ARE MORE LIKELY ATTRIBUTABLE TO WEAR OVER TIME RATHER THAN A LATENT MANUFACTURING DEFECT. THE PUMP HAD NO RECORD OF PRIOR WALKMED SERVICE. WHILE THERE IS NO DIRECT EVIDENCE LINKING THE MALFUNCTION TO THE PATIENT'S DEATH, THE CONFIRMED OUT-OF-SPEC PERFORMANCE CONSTITUTES A POTENTIAL RISK OF SERIOUS INJURY OR DELAY OF THERAPY. THIS MDR IS SUBMITTED IN ACCORDANCE WITH 21 CFR 803.50.

    Description of Event or Problem · 0

    A PATIENT UNDERGOING HOME INFUSION THERAPY USING A WALKMED 350VL AMBULATORY INFUSION PUMP (SERIAL NUMBER (B)(6)) EXPERIENCED CARDIAC ARREST ON (B)(6) 2025, WHILE RECEIVING 5-FU VIA CONTINUOUS INFUSION. THE PATIENT'S SPOUSE INITIATED CPR, AND EMERGENCY RESPONDERS PROVIDED FURTHER RESUSCITATION, BUT THE PATIENT WAS LATER PRONOUNCED DECEASED ON (B)(6) 2025 11:15 PM. THE INFUSION PUMP WAS STILL CONNECTED AT THE TIME OF THE EVENT. TIME OF DEATH DECLARED 22:15 PM (EXTENSIVE DOWNTIME) THE REPORTING FACILITY, VIA DISTRIBUTOR INFUSYSTEM, LATER INDICATED THAT THE CAUSE OF DEATH WAS DETERMINED TO BE A PULMONARY EMBOLISM AND DID NOT ATTRIBUTE THE OUTCOME TO A DEVICE MALFUNCTION. HOWEVER, DUE TO THE CIRCUMSTANCES, THE DEVICE WAS RETURNED TO WALKMED UNDER RGA #(B)(4) FOR EVALUATION. WALKMED CONDUCTED A VISUAL AND FUNCTIONAL EVALUATION PER SOP 100-601 USING FORM 100-601F6. THE PUMP FAILED PRESSURE PERFORMANCE TESTING AND EXHIBITED CLAMP BAR MALALIGNMENT, RESULTING IN IMPAIRED OCCLUSION DETECTION AND AN OUT-OF-SPEC PRESSURE PROFILE. THESE FINDINGS CONFIRM THAT THE DEVICE WAS NOT FUNCTIONING WITHIN DESIGN SPECIFICATIONS AT THE TIME OF EVALUATION. ALTHOUGH A DEFINITIVE CAUSAL LINK TO THE PATIENT'S DEATH HAS NOT BEEN ESTABLISHED, THE CONFIRMED FAILURE MODE PRESENTS A SIGNIFICANT RISK OF SERIOUS INJURY OR DELAY OF THERAPY IF THE MALFUNCTION WERE TO RECUR. IN ACCORDANCE WITH 21 CFR 803.50, THIS MEDICAL DEVICE REPORT IS SUBMITTED OUT OF AN ABUNDANCE OF CAUTION. NO AUTOPSY WAS PERFORMED. WALKMED HAS RECEIVED CONFIRMATION FROM THE FACILITY THAT THE ONLY AVAILABLE DOCUMENTATION IS THE HOSPITAL REPORT PREVIOUSLY PROVIDED. AVAILABLE CLINICAL DOCUMENTATION INDICATES THAT THE PATIENT HAD EXTENSIVE COMORBIDITIES, INCLUDING CHRONIC PULMONARY EMBOLISM, CONGESTIVE HEART FAILURE, AND PANCREATIC CANCER. WALKMED HAS REQUESTED ADDITIONAL CLINICAL DOCUMENTATION FOR ONGOING REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2519711 WALKMED® 350VL AMBULATORY INFUSION PUMP PUMP, INFUSION, PORTABLE FRN WALKMED TECHNOLOGIES, LLC WM350VL N/A 00859695006077

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Death| R 5-FLUOROURACIL (5-FU) INFUSION ADMINISTERED