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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SETS PUMP, INFUSION

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SMITHS MEDICAL ASD, INC. CADD ADMINISTRATION SETS PUMP, INFUSION Back to Search Results
Device Problems Fluid Leak (1250); Insufficient Flow or Under Infusion (2182)
Patient Problems Twitching (2172); Dizziness (2194)
Event Date 04/13/2021
Event Type  malfunction  
Event Description
Information was received indicating that during using of this smiths medical cadd administration sets, leaking was noticed. It was reported that patient call with pump and stated that she awoke around 4 am and was wet because pump had been leaking. The patient called the pharmacy earlier in the morning and was advised to make a new cassette and use backup pump, but patient stated that her husband mixes the cassettes and was going to call him to do so. Patient reported potentially off medication remodulin for an unknown period of time and was unclear where the leak was occurring. Patient also added that her iv line got tugged a few days ago and a few stitches fell out. Patient reported feeling somewhat weak, dizzy, and twitching hands. Patient doctor office was noticed. No additional adverse effects reported.
 
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Brand NameCADD ADMINISTRATION SETS
Type of DevicePUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11828986
MDR Text Key250798637
Report Number3012307300-2021-04363
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other,user facili
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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