MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET WITH FLOW STOP; SET, ADMINISTRATION

Model Number 21-7302-24

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

It was reported that the patient is due for cassette change.The patient is experiencing additional stomach aches since last mix.The patient has about 11 hours left on infusion.The pharmacy attempted to courier cassettes but advised the patient and wife to seek medical attention if the side effects worsen.No further information is known.The reported product fault occurred while in use with the patient but did not cause or contribute injury to the patient.Patient doesn't have additional cassettes to switch to, so the patient was instructed to go to er to continue the infusion.The infusion is life sustaining.The outcome of the event is still ongoing at time of report.

Manufacturer Narrative

Operator of device is unknown.No information has been provided to date.

Manufacturer Narrative

Other, other text: additional information provided in h6 and h10.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.No product was returned; therefore, the reported complaint could not be confirmed and the root cause could not be determined.

• Brand Name: CADD ADMINISTRATION SET WITH FLOW STOP
• Type of Device: SET, ADMINISTRATION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 16210229
• MDR Text Key: 308558258
• Report Number: 3012307300-2023-00564
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• 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: 03/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7302-24
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2023
• 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 Sex: Male