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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7323-24
Medical Device Problem Codes Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)
Health Effect - Clinical Code No Information (3190)
Date of Event 12/04/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that a customer found residual volume of 35 mls was left in the 250 ml bag after using a smiths medical admin set.The pump stated 248.3 mls infused from 250 ml bag.No adverse patient effects were reported.
 
Additional Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to manufacturing.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
CADD
Common Device Name
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11156193
Report Number3012307300-2021-00296
Device Sequence Number19850928
Product Code FPA
UDI-Device Identifier10610586039614
UDI-Public10610586039614
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K040636
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Nurse Practitioner
Type of Report Initial,Followup
Report Date (Section B) 05/28/2021
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 Expiration Date02/05/2025
Device Model Number21-7323-24
Device Catalogue Number21-7323-24
Device Lot Number3939042
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 12/14/2020
Supplement Date Received by Manufacturer05/01/2021
Initial Report FDA Received Date01/12/2021
Supplement Report FDA Received Date05/27/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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