MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7346-24

Device Problem Infusion or Flow Problem (2964)

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

Event Date 11/23/2021

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd administration set was under infusing (23.5%).No patient consequences were reported.No adverse effects were reported.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).An accuracy test was performed using the parameters already programmed into the pump by the customer.The delivery mode was intermittent.The standard administrative set was connected to a 1,000 ml intravenous bag primed with a separate pump then attached to pump.The end of the administration set was drained into a 400ml beaker.The pump was powered up and testing started.The pump ran without error for an hour pumping fluid from the intravenous bag into the beaker.When the test was complete the pump stopped.There was an accuracy error of 14 percent.Nothing was disconnected and the same test was attempted the next day.After approximately 10 minutes the pump started giving continuous downstream occlusion sensor errors but would then clear them immediately.The test was discontinued after approximately 30 minutes.The pump was tested by itself according to procedure on the automated test stand.The test was run three times and passed all three times with an average 1.61 percent accuracy for the three tests.With the pump and set together, it was ran one last time it was run into a calibrated cylinder for a total of 10 ml as reported by the pump.Both times, the pump under infused.Visual inspection of the set found the tubing toward the pivot side of the flow stop arm.The lab results do not match the negative 23.5 percent under delivery reported by the customer.The under delivery seen is consistent with the set sitting clamped (no blue clip) for 3 plus months and then attaching the pump (clamped at outlet valve) for 2 plus weeks.Complaint is not confirmed.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 13060263
• MDR Text Key: 282625259
• Report Number: 3012307300-2021-13153
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2023

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: 21-7346-24
• Device Catalogue Number: 21-7346-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 10/07/2022
• Supplement Dates FDA Received: 04/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1