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

Model Number 21-7346-24

Device Problem Failure to Prime (1492)

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

Event Date 12/17/2022

Event Type  malfunction  

Event Description

It was reported that the cadd pump tubing will not prime completely using pump.Tried 2 separate pumps with the same problem.The problem was detected before use or was not attached to patient.There was no serious harm reported.

Manufacturer Narrative

Premarket (510k) number is unknown.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.

Manufacturer Narrative

Other, other text: b5: additional information.H6: event problem and evaluation codes: updates not required.H10: 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.

Event Description

Additional information received on 5-jan-2023 via email and attached to complaint object: patient information is unknown.Obtained contact information and updated the complaint.

Manufacturer Narrative

Other, other text: additional information provided in h6 and h10.Device evaluation: the returned samples were received inside of plastic bag which is not its original packaging.The (b)(4) returned units were visually inspected at a distance of 12 to 16 inches under normal conditions of illumination.Sample no.1 and 2 were set for priming testing and after that was set for run.No discrepancies were detected, samples were fully priming and connected without difficulty, the pump was set running, liquid flowed through the whole device without interruptions, alarms were activated.On sample no.3, liquid was observed inside that could be the medication; for this reason, the sample was not tested, however an occlusion was identified between tube assembly to filter outlet bonding; thus, failure mode was confirmed.Based on the tests results, it is concluded that the failure could be reproduced in two ways: 1.When the excess of solvent is not cleaned before to assembly the tube with the component and 2.When the tube is introduced two times in the solvent dispenser (procedure was not followed).Action taken to mitigate this event: an awareness notification was issued by quality engineer to notify production personnel about the failure mode reported by the customer.The device history record (dhr) was reviewed and showed that this device met all manufacturing specifications for the product released for distribution; no issues were identified that would have impacted this event.

• 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): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 10030-107 street nw; minneapolis, MN 55442
• MDR Report Key: 16096706
• MDR Text Key: 308385815
• Report Number: 3012307300-2023-00073
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 15019517161953
• UDI-Public: 15019517161953
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• 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
• Device Lot Number: 4248635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1