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

Catalog Number	21-7359-24
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device not received by manufacturer.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Investigation is still in progress.
Event or Problem Description
It was reported that the patient came for disconnect but the pump finished approximately 6 hours early.The pump shows that there was drug left in the reservoir bag, but it was completely dry.A continuous infusion rate of 3 ml/hour had been programmed, with a total reservoir volume of 15 ml and given 100 percent of dose but bag was bone dry.The amount of medication remaining in the cassette did not match the reservoir volume displayed on the pump.They did not attempt to withdraw the remaining medication in the reservoir to confirm.There was no amount remaining, but it said there was 15 ml left in the bag.The air detector and the upstream sensor had been turned on.The length of the infusion intended had been set to 46 hours.The length of actual infusion had been set to 38-40 hours, but it was finished early.A cstd was used to fill the cassette.The pump was not used to prime the extension tubing.The line was primed using the syringe.The cstd manufacturer was bd.No patient harm or no patient injury.The event occurred while in use with patient at patient's home.The operator of the device was a health professional.Associated cassette complaint documented on (b)(4).
Additional Manufacturer Narrative
H3: the device history record of reported lot number 6108326 was reviewed, and it was confirmed that no non-conformities were reported during production.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.If the product is returned, the complaint will be reopened for further investigation.H11: this event is not reportable on the alleged device, as the reported issue suggests a malfunction of the pump.Please refer to report number 3012307300-2025-12154 for details related to this event.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.; ave calidad no. 4, parque; tijuana 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane n.; minneapolis, MN 55128 ; 2247062300
• MDR Report Key: 23478662
• Report Number: 3012307300-2025-12156
• Device Sequence Number: 13319009
• Product Code: FPA
• UDI-Device Identifier: 10610586027406
• UDI-Public: (01)10610586027406(17)300416(10)6108326
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K040636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 21-7359-24
• Device Lot Number: 6108326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2025
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown