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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7094-24
Device Problem Mechanical Problem (1384)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
Event Type  malfunction  
Event Description
It was reported the device caused the attached pump to give false "upstream occlusion" or "high pressure" alarm message after infusion had been started.No adverse effects reported.
 
Manufacturer Narrative
H6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection results: no abnormality were detected during visual inspection in none of the samples, no obstructions nor kinks were detected in none of the samples.Functional test: the complaints sample was tested using the cadd pump legacy to prime the devices as instruction of use as10011952-002 indicate.No difficulty was detected during the priming and no alarms were activated; the water could pass through the whole devices; thus, the failure mode reported was not confirmed.Root cause could not be determined since the complaint was not confirmed due to the fact the sample was tested and successfully passed.No corrective actions are required since the complaint was not confirmed.A dhr review was performed and no problems or issues were identified during this dhr review.
 
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Brand Name
CADD ADMINISTRATION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
davutpasa cd. no:4
minneapolis, MN 55442
MDR Report Key12222768
MDR Text Key263364642
Report Number3012307300-2021-07636
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586025266
UDI-Public10610586025266
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K933390
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number21-7094-24
Device Catalogue Number21-7094-24
Device Lot Number4048931
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/20/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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