MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTE RESERVOIR WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7308-24

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/15/2021

Event Type  malfunction  

Event Description

It was reported that the patient's mother found the patient deceased and still hooked up to the pump and receiving infusion.The patient's treatment was palliative.Emergency medical services (ems) was contacted, removed the pump from the patient, and gave it to the patient's mother.The death was reported as an unexpected event and the cause is unknown.

Manufacturer Narrative

No additional information was received.Patient code and device code unknown due to limited information provided.There was no allegation against the cassette reservoir.This event is being reported as it is associated with the death of a patient.No product sample was received; therefore, visual, and functional testing could not be performed.A device history record (dhr) review was performed, and no issues were noted during manufacture.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR WITH FLOW STOP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 15294803
• MDR Text Key: 305263527
• Report Number: 3012307300-2022-16230
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586032370
• UDI-Public: 10610586032370
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081156
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7308-24
• Device Catalogue Number: 21-7308-24
• Device Lot Number: 4135439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/23/2022
• Initial Date FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1