MAUDE Adverse Event Report: SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. CADD MEDICATION CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	21-7343-24
Medical Device Problem Codes	Complete Blockage (1094); Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
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 pump gives an air alarm even if there is no air in the pipe.The alarm could not be rectified by any means.The pump was replaced, and the problem persists.It was determined there were no problems with the pump, the problem was solved by replacing the admin sets.The event has occurred during infusion at the patient's home.The user was the patient, but the infusion was given by the carer.The patient was not harmed during the event.
Additional Manufacturer Narrative
H6: evaluation codes updated.Device evaluation: ten sealed/unused samples were received.No damages or other defects were detected on the sample visually.The samples were tested using the hydrostatic pressure vessel as the procedure indicates.A pump alarm was not detected; the failure mode reported was not confirmed.Retrospective review was performed to p/n 21-7343-24 lot number 4448943, for a period of dec 2023 to nov 2024, no complaints related to the same failure mode and same lot number was reported.

• Brand Name: CADD MEDICATION CASSETTE RESERVOIR
• 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 lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20622588
• Report Number: 3012307300-2024-12837
• Device Sequence Number: 8874216
• Product Code: FPA
• UDI-Device Identifier: 15019517191820
• UDI-Public: (01)15019517191820(17)281205(10)4448943
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2024

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: 21-7343-24
• Device Lot Number: 4448943
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 11/06/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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
• Patient Sex: Unknown