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

Model Number 21-7106-24

Device Problems Device Alarm System (1012); Failure to Sense (1559); Output Problem (3005)

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

Event Type  malfunction  

Event Description

Information was received indicating that during use of this smiths medical cadd extension sets, the patient reported that the pump exhibited intermittent alarms of "upstream occlusion".No patient injury reported.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated after device evaluation.H10: device evaluation: the device was returned for investigation in used conditions without its original packaging.Functional test: sample was tested using a syringe with colored water to detect any occlusion.Results: during the test, the water did not pass-through filter.The complaint was confirmed.Conclusion: based on the tests results, it is concluded that the failure could be reproduce in two ways: 1.When the excess of solvent is not cleaned before to assembly the tube with the component.2.When the tube is introduced two times in the solvent dispenser (procedure is not followed).The cause of the reported problem was traced to the manufacturing process.Q alert 21082 was generated to ensure adherence to manufacturing procedure related to clean the excess of solvent before to assemble tube with the component.Personnel notification was performed on (b)(6) 2021 to notify production personnel about the failure mode reported by the customer.

• Brand Name: CADD EXTENSION SETS
• 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: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 11881097
• MDR Text Key: 252713550
• Report Number: 3012307300-2021-05037
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K974013
• 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: 02/21/2022

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 Model Number: 21-7106-24
• Device Catalogue Number: 21-7106-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 02/16/2022
• Supplement Dates FDA Received: 02/21/2022
• 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