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

Catalog Number	21-7345-24
Medical Device Problem Codes	Defective Alarm (1014); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device had air in line.Per reporter, after about 42 hours the patient arrived back at clinic.There was a significant amount of air noted between the pump and filter.The bag still had ~300 ml ivf left, and the pump continued to run with no alarm that there was air in line.There was no air between filter and patient, so air did not appear to have reached patient.They stopped the pump, notified lip, pharmacy.The pump was returned to the pharmacy.A new pump/ivf bag was connected to the patient with instructions to keep the pump at/above heart level and to stop pump immediately if air was noted in the tubing.The patient showed no symptoms of distress/air embolism while in pacc.The event occurred at the patient's home and was operated by a health professional.There was patient involvement, and no patient harm/adverse event reported.
Additional Manufacturer Narrative
E1: reporter facility name (b)(6) - (memorial sloan-kettering cancer center) no product was returned.The reported complaint could not be confirmed.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 this complaint will be reopened for further investigation.Neither samples or pictures were received for the analysis of this complaint.No device history record was reviewed since lot number was not provided.

• Brand Name: CADD ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 22425
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 20451005
• Report Number: 3012307300-2024-11129
• Device Sequence Number: 15593256
• Product Code: FPA
• UDI-Device Identifier: 15019517191714
• UDI-Public: (01)15019517191714
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K031361
• 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
• Report Date (Section B): 10/15/2024

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: 21-7345-24
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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