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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD PUMP MS3; PUMP, INFUSION

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SMITHS MEDICAL ASD, INC. CADD PUMP MS3; PUMP, INFUSION Back to Search Results
Device Problem No Flow (2991)
Patient Problem Missed Dose (2561)
Event Date 10/01/2020
Event Type  Injury  
Event Description
Spontaneous call from pt's husband to report pump issue with ms3 pump with serial number (b)(4).Pump stopped working in the middle of the night and pt ran out of medication for over 4 hours.No injury to pt.Pt did not have or feel the pump alarm when pump ran out of medication.Pump should not have run out of medication until this evening.Pt is switching to back up pump.Pump will be replaced and malfunctioning.Pump will be returned.No other info known.Did we replace device? yes.Did the patient have a backup device they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.What is the outcome of the event? she restarted her medication with no issues.Did the reported product fault occur when in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual device available for investigation? yes.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
CADD PUMP MS3
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
minneapolis MN
MDR Report Key10657186
MDR Text Key211030291
Report NumberMW5097160
Device Sequence Number1
Product Code FRN
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/08/2020
Patient Sequence Number1
Patient Age75 YR
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