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

Model Number 21-7394-24

Device Problem Restricted Flow rate (1248)

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

Event Date 11/02/2022

Event Type  malfunction  

Manufacturer Narrative

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 the patient went to the clinic to disconnect the pump which showed that there was zero volume remaining.However, upon reviewing the medication bag the next day it was noticed that there were 160 milliliters of medication remaining in the bag which means that the patient had received only 70 percent of the dose.Upon review of the pump settings, it showed that it was programmed correctly but somewhere between the time the infusion started and the patient was disconnected, the rate had changed to 0.4 milliliters.It also appeared that the pump had alarmed during the night.No patient injury was reported.

Manufacturer Narrative

B5: additional information received via email from customer on 4-nov-2022 and attached in complaint: the pump looks like it was programed correctly but somewhere between the time the infusion started and the patient came back to be disconnected, the rate changed to 0.4 ml.Also, it appears that the pump was alarming at night, and i wanted to know if the patient called the service center to alert them.I have the drug, with the iv bag and tubing still connected for your review.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.

Manufacturer Narrative

Other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.Visual inspection was performed.No damages or other defects were detected on the sample.It was observed that the blue clip was missing.Functional test was not performed, during the set for accuracy test the program showed that the pump was not delivering, which confirmed the customers reported problem.The root cause investigation identified flow stop feature differences between arm occlusion molded parts as the major cause factor.For corrective action, containment action was performed which allowed assembly workers in disposable lines to use primary component.Root cause of the reported issue was traced to the supplier and the manufacturing process.An internal capa was opened on 16/may/2022 to investigate the under-delivery/ non-delivery issue.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).There were no relevant findings detected in the device history record.Review of batch history records confirmed the reported lot 4248641 met acceptance requirements.Review of field data found no trends relevant to this product and issue.

• 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: 15764913
• MDR Text Key: 307466831
• Report Number: 3012307300-2022-26990
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027536
• UDI-Public: 10610586027536
• 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: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2023

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: Health Professional
• Device Model Number: 21-7394-24
• Device Catalogue Number: 21-7394-24
• Device Lot Number: 4248641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 11/04/2022; 01/06/2023
• Supplement Dates FDA Received: 11/28/2022; 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1