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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD
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ST PAUL CADD Back to Search Results
Model Number 21-7339-24
Medical Device Problem Codes Leak/Splash (1354); Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 01/01/2020
Type of Reportable Event Malfunction
Event or Problem Description
Information was received indicating that cadd administration sets - flow stop is not able to be primed.The pump indicates that 10 cc was primed.There's also suspicion that the tube is leaking.The infusion was for ropivacaine and fentanyl.There were no adverse events reported.
 
Additional Manufacturer Narrative
Other, other text: additional information: d10, h6, h10: device evaluation: one smiths medical cadd administration set was returned for analysis.During analysis the returned sample was primed using a cadd solis pump in order to look for any difficulty; the water could flow through the whole set; it was possible to be primed without any difficulty.Based on the evidence, the complaint was not confirmed, and no fault was found.
 
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Brand Name
CADD
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10192922
Report Number3012307300-2020-06237
Device Sequence Number908601
Product Code FPA
UDI-Device Identifier10610586027307
UDI-Public10610586027307
Combination Product (Y/N)N
PMA/510(K) Number
K040636
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 09/30/2020
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 No Information
Device Expiration Date10/21/2024
Device Model Number21-7339-24
Device Lot Number3891203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/12/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 05/25/2020
Supplement Date Received by Manufacturer09/09/2020
Initial Report FDA Received Date06/24/2020
Supplement Report FDA Received Date09/30/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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