MAUDE Adverse Event Report: SPECTRUM MEDICAL S.R.L. QUANTUM PERFUSION DUAL LUMEN CANNULA DL31F

Model Number	DL31F-V0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	06/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information related to the event will be available after investigation of returned device, which would be addressed in a follow-up report.
Event or Problem Description
(b)(6), placed their first cannula (31fr) on saturday.Cannula dislodged while trying to remove the obturator.During second attempt could not remove obturator.Small kink in rv.Clinician stated patient went to ct for possible rv wall injury and bronchial arterial bleed.Cannula still in use, will request return once the cannula is removed.
Additional Manufacturer Narrative
No investigation could be possible since the device has been disposed off by the hospital at the end.Nevertheless, no further investigation or corrective actions have deemed required for the following reasons: - since the kinking could not have occurred with the introducer in place, it is assumed that the cannula was not correctly positioned in relation to the patient's anatomy.- the clinical procedure was anyway successfully completed.- all indications for use and warnings are already included in the instructions for use.
Event or Problem Description
Prisma columbia placed their first cannula (31fr) on saturday.Cannula dislodged while trying to remove the obturator.During second attempt could not remove obturator.Small kink in rv.Clinician stated patient went to ct for possible rv wall injury and bronchial arterial bleed.Cannula still in use, will request return once the cannula is removed.

• Brand Name: QUANTUM PERFUSION DUAL LUMEN CANNULA DL31F
• Common Device Name: DUAL LUMEN CANNULA
• Manufacturer (Section D): SPECTRUM MEDICAL S.R.L.; via di mezzo, 23; mirandola, modena 41037 ; IT 41037
• Manufacturer (Section G): SPECTRUM MEDICAL S.R.L.; via di mezzo, 23; mirandola, modena 41037 ; IT 41037
• Manufacturer Contact: raffaella tommasini ; via di mezzo, 23; mirandola, modena 41037 ; IT 41037
• MDR Report Key: 22392355
• Report Number: 3016746283-2025-00005
• Device Sequence Number: 15743271
• Product Code: DWF
• UDI-Device Identifier: 08051160300792
• UDI-Public: (01)08051160300792(17)260220(10)G001179
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K221353
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/20/2026
• Device Model Number: DL31F-V0
• Device Lot Number: G001179
• 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: 06/09/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 09/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/20/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown