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

Catalog Number	21-7052-24
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	09/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient was without drug for twenty minutes as the device was not working.Per reporter the device exhibited a "high priority alarm".The device had been changed to a new cassette that weekend, but it began alarming while the patient was in town.The home screen indicated a high priority alarm.Downstream occlusion and did not clear for twenty minutes.The reporter further noted that troubleshooting was performed by the patient where they changed to a different device, infusion line batch, cassette batch and the device in an effort to isolate the cause.The patient was able to get home and re-establish the infusion using a new system with no further issues.There was patient involvement, and no patient harm reported.
Additional Manufacturer Narrative
E1: initial reporter phone: (b)(6).H3: neither samples nor pictures were received for the analysis of this complaint the device history record of reported lot number: 4342624 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.

• 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: 20335229
• Report Number: 3012307300-2024-10240
• Device Sequence Number: 9574270
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: (01)10610586020346(17)271209(10)4342624
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

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: 21-7052-24
• Device Lot Number: 4342624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/23/2022
• 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