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

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.

• 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 Key: 16094768
• MDR Text Key: 308527142
• Report Number: 3012307300-2023-00043
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 01/04/2023
• Supplement Dates Manufacturer Received: 06/28/2023; 08/21/2023
• Supplement Dates FDA Received: 06/29/2023; 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 Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Sex: Female