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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7047-24
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2023
Event Type  malfunction  
Event Description
It was reported that the cassette bag was emptied however the pump displayed that there was more chemo to infuse.No alarm was noted, however there was a possibility of a no disposable alarm.No patient injury was reported.
 
Manufacturer Narrative
Other text: no product was returned.The reported issue cannot be confirmed as no product was returned for investigation.If the product is returned, this complaint will be reopened for further investigation.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.
 
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Brand Name
CADD EXTENSION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key18212561
MDR Text Key329080727
Report Number3012307300-2023-10779
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586020315
UDI-Public10610586020315
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K942046
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number21-7047-24
Device Lot Number4381330
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/03/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/18/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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