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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTES SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD MEDICATION CASSETTES SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7322-24
Device Problem Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2022
Event Type  malfunction  
Event Description
It was reported that a cadd had almost a full bag of medication remaining. Pump was programmed correctly. Outer lumen of port that cadd was connected to did not flush and had no blood return. No patient injury was reported.
 
Manufacturer Narrative
No product or photographic evidence were provided to aid in this investigation. The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications. Lacking any additional evidence, this complaint has been closed as unconfirmed. If the product is returned, smiths medical will reopen this complaint for further investigation. A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.
 
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Brand NameCADD MEDICATION CASSETTES
Type of DeviceSET, 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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key14318170
MDR Text Key291243937
Report Number3012307300-2022-08010
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586029646
UDI-Public10610586029646
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7322-24
Device Catalogue Number21-7322-24
Device Lot Number4230900
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/13/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No

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