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

Device Problem Connection Problem (2900)

Patient Problems Headache (1880); Unspecified Infection (1930); Sore Throat (2396)

Event Type  malfunction  

Event Description

It was reported that 'per mw5113217 patient reports having a cassette malfunction in the last week.She said the alarm sounds and displays no cassette.She said it happens a day after she hooks up the cassette (when the cassette is half full).She said this has been an ongoing issue.She did save the cassette to send back for investigation, but she could not locate a lot number on the cassette.She said she tries to hook the cassette to the spare pump and it gives the same alarm, so then she hooks up a brand new cassette and the issue is resolved.Patient also reports sinus infection, sore throat, headache, and flu like symptoms in the last several weeks, but thinks it was due to the opsumit, which she quit taking.She said her medical doctor is aware.No further information provided.No injury.'.

Manufacturer Narrative

Udi and catalog information are 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.

Manufacturer Narrative

Other text: b5: additional information.H6: event problem and evaluation codes: updates not required.H10: device evaluation 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

Additional information received on (b)(6) 2022 via email and attached to complaint object: patient details updated in complaint.

• 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: 15874191
• MDR Text Key: 307694744
• Report Number: 3012307300-2022-27499
• 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
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 12/02/2022
• 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 Sex: Female