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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CADD; SET, ADMINISTRATION, INTRAVASCULAR
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CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 7300
Medical Device Problem Code Device Alarm System (1012)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/02/2021
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a smiths medical pump displayed a no disposable alarm right at the initial hookup of the pump.No further information available.
 
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Brand Name
CADD
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12571747
Report Number3012307300-2021-09750
Device Sequence Number4111931
Product Code FPA
UDI-Device Identifier10610586029639
UDI-Public10610586029639
Combination Product (Y/N)N
Initial Reporter StateKS
Initial Reporter CountryUS
PMA/510(K) Number
K040636
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number7300
Device Catalogue Number21-7321-24
Device Lot Number4136400
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/06/2021
Initial Report FDA Received Date10/04/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) No
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device N
Patient Sequence Number1
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