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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD MS3 PUMPS; PUMP, INFUSION
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ST PAUL CADD MS3 PUMPS; PUMP, INFUSION Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Type  Injury  
Event Description
It was reported that the patient had shortness of breath and increased pulse rate.No patient injury was reported.
 
Manufacturer Narrative
D4: udi and catalog number are unknown.This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.
 
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Brand Name
CADD MS3 PUMPS
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key17006731
MDR Text Key315991646
Report Number3012307300-2023-05674
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 05/25/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/20/2023
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
Patient Outcome(s) Hospitalization;
Patient SexFemale
Patient Weight52 KG
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