MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD ADMINISTRATION SET WITH AIR-ELIMINATING FILTER; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7094-24
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 disposable caused the device to exhibit an error message: check for empty tubing or reservoir.Troubleshooting was performed but the alarm persisted.No adverse patient effects were reported by the customer.
Additional Manufacturer Narrative
Two samples were returned for evaluation.Visual inspection revealed no damage or other defects.Functional testing revealed no discrepancies.The failure mode was not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.D9: date returned to mfg 3/4/2024.

• Brand Name: CADD ADMINISTRATION SET WITH AIR-ELIMINATING FILTER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana ; MX
• Manufacturer Contact: reed covert ; 6000 nathan ln n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18703706
• Report Number: 9617604-2024-00135
• Device Sequence Number: 12600674
• Product Code: FPA
• UDI-Device Identifier: 10610586025266
• UDI-Public: 10610586025266
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K933390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2024

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: Lay User/Patient
• Device Catalogue Number: 21-7094-24
• Device Lot Number: 4415281
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 02/14/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PUMP
• Patient Sex: Unknown