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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-MS3 AMBULATORY INFUSION PUMP; PUMP, INFUSION
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SMITHS MEDICAL ASD, INC. CADD-MS3 AMBULATORY INFUSION PUMP; PUMP, INFUSION Back to Search Results
Model Number 7400
Device Problem Failure to Infuse (2340)
Patient Problems Discomfort (2330); Patient Problem/Medical Problem (2688)
Event Date 01/12/2020
Event Type  Injury  
Event Description
Information was received indicating that a smiths cadd-ms3 ambulatory infusion pump had a full cartridge and had not infused an medication for the past 48 hours.The patient noted that she "felt really bad" during that period.The issue was resolved by sending the patient a replacement pump via emergency courier.The pump was pumping remodulin 80nkm continuously subcutaneously for pulmonary arterial hypertension.There were no reported adverse events.
 
Event Description
Investigation results completed on a smiths medical device.Correction data also included in final report.Summary in h 10.
 
Manufacturer Narrative
Investigation results completed on a smiths medical cadd ms3 pumps.Summary revealed complaint was verified and isolated to motor issue.Other issues were found on device but summarized s161 c165 r122.Motor was replaced and dhr review found no discrepancies in device prior to release.Sr.Consultant - product safetyadditional contact:dawn prazenica consultant, specialty pharmacovigilance and product safety p (b)(4).Cvs health (b)(6).
 
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Brand Name
CADD-MS3 AMBULATORY INFUSION PUMP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
MDR Report Key9695058
MDR Text Key178611920
Report Number3012307300-2020-00984
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number7400
Device Catalogue Number21-7411-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2020
Date Manufacturer Received01/14/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age56 YR
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