MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; PUMP, INFUSION

Model Number	21-2120-0105-231
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that the cadd pump air in line detector was bad and needed to be replaced.No patient injury reported.
Additional Manufacturer Narrative
Other text: additional information is provided for h.2, h.3, and h.6.One device was received for evaluation.Visual inspection revealed the device had no physical damage.Functional testing was performed, and the reported issue was able to be replicated and confirmed.The root cause was determined to be air in the line.Service history review identified the complaint was not related to a previous service of the device within the review period.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: CADD
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16791462
• Report Number: 3012307300-2023-04389
• Device Sequence Number: 5554271
• Product Code: FRN
• UDI-Device Identifier: 15019517150568
• UDI-Public: 15019517150568
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K111275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2024

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
• Operator of Device: Other
• Device Model Number: 21-2120-0105-231
• Device Catalogue Number: 21-2120-0105-231
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/21/2023
• Supplement Report FDA Received Date: 04/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown