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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIRS - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD CASSETTE RESERVOIRS - NON FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Inaccurate Delivery (2339)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2023
Event Type  malfunction  
Manufacturer Narrative
D4 and g5 are unknown; no further information provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported the pump stopped early and there was no medication left in the bag; there should have been 4.6ml or 2 hours left for infusion.No adverse patient effects were reported by the customer.
 
Manufacturer Narrative
Email is: (b)(6).Manufacture date unavailable.One device was returned for evaluation.Visual inspection revealed no anomalies.Functional testing could not replicate the reported issue.The root cause could not be determined.No corrective actions were required or taken.No lot number was provided; therefore, a history record review could not be conducted.
 
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Brand Name
CADD CASSETTE RESERVOIRS - NON FLOW STOP
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 Key17078058
MDR Text Key316680251
Report Number3012307300-2023-06025
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Returned to Manufacturer06/02/2023
Was the Report Sent to FDA? No
Date Manufacturer Received07/31/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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