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

Catalog Number	21-7046-24
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Air/Gas in Device (4062)
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
E1: facility name (b)(6).H3/h6: neither samples nor pictures were received for the analysis of this complaint.No device history record was reviewed since lot number was not provided.Without the return of the used 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.
Event or Problem Description
It was reported that the device had an internal quality assurance on their infusions and noticed an increased trend of air in line alarms along with infusion ending 2.5 hours early.Per reporter, it had an air in line that was firing.The customer calculated delivery accuracy and some cases the infusion was in the spec, but in others the accuracy ranges from 11.5% up to 21%.The product fault occurred while in use with a patient.No patient harm/adverse event reported.
Additional Manufacturer Narrative
Additional information received.See section a and d.B5: additional information was received that it was unclear if side effects reported by the patient were a result of receiving extra 5fu versus other systemic chemotherapy.There was a patient involvement and unknown patient harm/adverse event reported.H3: device was not returned for root cause analysis.Without the return of the samples a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.The quality inspection forms were reviewed, and it was observed that no defects were found, and the lot was released.Complaint could not be confirmed and without the return of the used samples, a comprehensive failure investigation could not be performed, and a probable could not be determined.

• Brand Name: CADD CASSETTE
• 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: 20246610
• Report Number: 3012307300-2024-09451
• Device Sequence Number: 7312251
• Product Code: FPA
• UDI-Device Identifier: 10610586020308
• UDI-Public: (01)10610586020308(17)290401(10)6005734
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2024

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: 21-7046-24
• Device Lot Number: 6005734
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2024
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 85 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White