MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	7052
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	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: unknown; no information has been provided to date.H3: neither samples nor pictures were received for the analysis of this complaint.The device history record of reported lot number: 4434723 was reviewed and it was confirmed that no non-conformities were reported during production.The review of the quality inspection forms identified no defects, 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.
Event or Problem Description
It was reported that the device exhibited a downstream occlusion alarm.Per reporter all the faulty lines were causing the alarm.It was initially believed that the issues were caused by the pumps as when they tried to prime, the pumps did 0.1 ml then occluded.The reporter noted that this only happened with flow stop cartridges and happened sporadically.It was discovered afterwards that the extension sets actually caused the issue because a client had already tried exchanging the pumps in order to solve the issue.It was further noted that it was still unknown whether the pumps had issues as well.The issue was discovered during set up at the patient's home.There was patient involvement, and there were no signs or symptoms experienced.

• Brand Name: CADD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20304629
• Report Number: 3012307300-2024-09915
• Device Sequence Number: 7726612
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: (01)10610586020346(17)281016(10)4434723
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K974013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2024

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 Model Number: 7052
• Device Catalogue Number: 21-7052-24
• Device Lot Number: 4434723
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/27/2023
• 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 Age: 59 YR
• Patient Sex: Unknown
• Patient Weight: 60 KG
• Patient Race: White