MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SETS - FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7357-24
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other text: 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.Email is: (b)(6).
Event or Problem Description
It was reported a patient had on a high volume infusion overnight and it had air in line at the end of the infusion that was not detected.There was approximately 70.2 ml left of the 2l infusion.No adverse patient effects were reported by the customer.Pump settings: rate: 91 ml/hour; amount given: 1929.8 ml reservoir volume: 70.2 ml.Drug regimen: 3680 mg mesna in 2000 ml ns cadd pump infusion over 22 hours.Start time was 14:45 on (b)(6) 2023, end time was 12:04 on (b)(6) 2023.
Additional Manufacturer Narrative
Sample was received; device not returned.
Additional Manufacturer Narrative
Other text: additional information is provided for h.2 and h.6.One sample was received for evaluation.Visual inspection revealed the sample was received in a plastic bag, not its original packaging and in used conditions; no damage or defects were noted.Functional testing was performed, and the reported issue could not be replicated.The root cause could not be determined.Device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.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 ADMINISTRATION SETS - FLOW STOP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert
• MDR Report Key: 18288290
• Report Number: 3012307300-2023-10982
• Device Sequence Number: 6668275
• Product Code: FPA
• UDI-Device Identifier: 10610586027390
• UDI-Public: 10610586027390
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2024

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: Health Professional
• Device Catalogue Number: 21-7357-24
• Device Lot Number: 4381347
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 12/05/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2023
• Supplement Date Received by Manufacturer: 02/29/2024; 04/02/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 03/11/2024; 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2023
• 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