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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. SMITHS CADD VIP; PUMP, INFUSION

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SMITHS MEDICAL ASD, INC. SMITHS CADD VIP; PUMP, INFUSION Back to Search Results
Device Problems Defective Alarm (1014); Flushing Problem (1252); Defective Component (2292); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/11/2021
Event Type  malfunction  
Event Description
Purpose of visit: 5fu disconnect.Upon inspection, chemo bag was completely full.Solis pump reading "running" under a "green" label.Pump reading "time remaining" 11 minutes etc.Event log reviewed, every 15 minutes logged showed 0.75mls/hr infused which equates to 3mls/hr upon further inspection, unable to flush port.This rn pushed in on port needle and port flushed freely.Upon removing dressing, visualized moisture under drsg and guardiva patch soaked.Call to dr to report.Spoke to her nurse who reported off to the covering md as following md was off today.Rn will call the infusion clinic and speak to the nurse who accessed him and request a steri strips and a larger drsg be placed next time to mitigate this from happening again pump will be returned to the pharmacy for inspection and to determine why the pump never alarmed.Pump returned to the pharmacy.Pump log run and no errors identified.Fda safety report id# (b)(4).
 
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Brand Name
SMITHS CADD VIP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key12086636
MDR Text Key259185028
Report NumberMW5102186
Device Sequence Number2
Product Code FRN
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 06/24/2021
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/28/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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