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

Device Problem Device Alarm System (1012)

Patient Problems Diarrhea (1811); Headache (1880); Pain (1994)

Event Type  malfunction  

Manufacturer Narrative

Udi and catalog information are unknown.G5: 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 per medwatch (b)(4) spontaneous call from patient.Spoke to patient she is still experiencing some headaches, jaw pain and diarrhea.Says her medical doctor is aware of this, and the side effects are tolerable.Advised patient if the side effects become worse or new side effects occur to let us and the medical defense officer know.Patient understood.Patient did have an issue with a cassette approximately a week ago.The reported product fault did occur while in use with a patient.The product issue did not cause or contribute to patient or clinical injury.The event is resolved.This incident has happened within the past 6 months.This patient has reported a pump malfunction within the past 6 months.Patient had her pump replaced recently.Her husband drew up another mix and replaced the cassette and the issue resolved.Patient is doing well.Patient did not save cassette.Patient unsure of exact type of alert, just that it was a no disposable.Alert no other info/dates provided.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual cassette available for investigation? no.Did we replace the cassette? she is ordering refill today.Did the patient have additional cassettes they were able to switch to? yes.If yes, was the patient able to successfully continue their infusion? yes.Is the infusion life sustaining? yes.What is the outcome of the event? resolved.Reported to, by patient caregiver.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updates not required.H10: the device was not returned for investigation for the reported issue; no visual inspection and functional test were performed.Based on the fact that no product was returned, the investigation was unable to confirm the reported complaint.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• 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: 15584114
• MDR Text Key: 306992842
• Report Number: 3012307300-2022-23403
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2022
• 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 Age: 57 YR
• Patient Sex: Female