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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7349-24
Device Problem Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2022
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: no product was returned. We are unable to confirm the reported complaint. If the product is returned, smiths medical will reopen this complaint for further investigation.
 
Event Description
It was reported the set wouldn't infuse. Checked tubing placement in cassette and tried again and infused but then started dripping once infusion had been stopped. Originally came to biomed shop with error of -not infusing- which was confirmed. Tested pump with a known good admin set without issues and pump was within mfg specs. Several pumps are in shop to be tested with the same reported failures. All, so far, have passed without any issues. No patient injury was reported.
 
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Brand NameCADD
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key14349448
MDR Text Key291362627
Report Number3012307300-2022-08444
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517184235
UDI-Public15019517184235
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 05/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7349-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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