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

Model Number 21-7322-24

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter occupation: is administrator/supervisor.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 two incidents were reported that the patient did not get their medications.Pump, set up, etc.Were all tested and still could not identify the issue.The tubing set is suspected.This affects patient safety and delay of care and the health care team has concerns.This file reflects the second incident.No patient injury was reported.

Manufacturer Narrative

Additional information received on 08-aug-2022 via email and attached to complaint object: patient details updated in complaint.Patient came to the infusion center to be un-hooked from his 24 hour fluorouracil (5fu) pump and to get his neulasta on-pro.Upon disconnection of the pump, 5fu bag was noted to be still full.Patient stated that the pump didn't beep throughout the time that he was connected to it.Bag's total volume was 136 ml.Patient was supposed to get 120 ml of 5fu.Bag upon disconnection is noted to be full.There was no death or injury.The event has been resolved.Medical intervention was required: per physician?s order, patient was to skip this chemo dose.Event log is available for the specific pump if needed.The device is not available for return.The event was discovered during the removal/end of therapy at the infusion center.Operator of device: health professional.The quantity affected is unknown.Customer did not report the event to the fda.H6: event problem and evaluation codes: updates not required.

Manufacturer Narrative

H6: event problem and evaluation codes: updates not required.H10: no lot number was provided; therefore, device history record review could not be completed.Device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• Brand Name: CADD ADMINISTRATION SET 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): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15051783
• MDR Text Key: 304709674
• Report Number: 3012307300-2022-13566
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029646
• UDI-Public: 10610586029646
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7322-24
• Device Catalogue Number: 21-7322-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/09/2022
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic