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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 21-7394-24
Device Problems Volume Accuracy Problem (1675); Calibration Problem (2890)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Event Description
Information was received indicating that while using cadd administration sets - flow stop an internal volume check was performed and an under-delivery variance of 8% - 15% was noted.There was no patient involved.
 
Manufacturer Narrative
Eight cadd administration sets were returned for analysis.Upon visual inspection, no damages were observed but the arch height pump tube was found low.The samples were set for accuracy testing using a pump solis vip; all samples failed the testing.The manufacturing process was reviewed; no discrepancies found.Based on the evidence, the complaint was confirmed.The root cause was found due to manufacturing.
 
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Brand Name
CADD
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10149243
MDR Text Key194992364
Report Number3012307300-2020-05852
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027536
UDI-Public10610586027536
Combination Product (y/n)N
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 08/10/2020
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
Device Operator No Information
Device Model Number21-7394-24
Device Lot Number3925422
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/13/2020
Initial Date FDA Received06/12/2020
Supplement Dates Manufacturer Received07/12/2020
Supplement Dates FDA Received08/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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