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U.S. Department of Health and Human Services

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

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ST PAUL CADD MEDICATION CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Dyspnea (1816)
Event Date 12/16/2022
Event Type  Injury  
Manufacturer Narrative
Catalog number is unknown.Udi information is unknown.Premarket (510k) number is unknown.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 that the patient experienced shortness of breath when getting dressed.The patient reported the shortness of breath was slight, and the patient was instructed to seek medical help if the problem persisted.The patient was using a cassette affected by a recall, but it was unknown if this caused the shortness of breath.The patient reported that they had no cassettes to use for later that night.The distributor agreed to send the patient more cassettes.The shortness of breath occurred while the product was in use with the patient.The patient was receiving 10mg/ml remodulin at a dose of 47ng/kg/min.It was reported that no medical intervention was required.The product is available for investigation, and the issue is considered resolved.No patient injury was reported.Additional information was received by the manufacturer on 22-dec-2022 via email.It was reported that the event occurred on (b)(6) 2022.The pharmacy reported that they will follow up with the patient to confirm the product return availability and provide an update once one it is available.All other requested information was unknown.
 
Manufacturer Narrative
Serious injury.
 
Manufacturer Narrative
The reported complaint could not be confirmed.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 MEDICATION CASSETTE
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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key16094768
MDR Text Key308527142
Report Number3012307300-2023-00043
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 Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 09/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/20/2022
Initial Date FDA Received01/04/2023
Supplement Dates Manufacturer Received06/28/2023
08/21/2023
Supplement Dates FDA Received06/29/2023
09/06/2023
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) Other;
Patient Age64 YR
Patient SexFemale
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