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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 Date 05/01/2020
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
Other, other text: 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 Key10151264
MDR Text Key195070103
Report Number3012307300-2020-05873
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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