MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS WITH AIR-ELIMINATING FILT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7394-24

Device Problem Failure to Deliver (2338)

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

Event Date 05/06/2022

Event Type  malfunction  

Manufacturer Narrative

Operator of device: patient/consumer.No product has been returned to date.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 a patient was connected to the bag but it was discovered that the medication was not infused.Upon review of the pump's event log, it showed infusion was complete.Also, a simulation of the same settings was setup utilizing another set and the pump ran for the same duration; all testing came back within the specifications.No patient injury was reported.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: update not required.H10: no lot number was provided; therefore, device history record review could not be performed.No product sample nor photos were received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4)., corrected data: b1: adverse event and/or product problem.

• Brand Name: CADD ADMINISTRATION SETS WITH AIR-ELIMINATING FILT
• 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: 14646790
• MDR Text Key: 294029534
• Report Number: 3012307300-2022-11355
• 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
• Report Date: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7394-24
• Device Catalogue Number: 21-7394-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2023
• 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