MAUDE Adverse Event Report: SPECTRUM MEDICAL S.R.L. QUANTUM PERFUSION DUAL LUMEN CANNULA DL27

Model Number	DL27F-V0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2025
Type of Reportable Event	Malfunction
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
On friday evening, customer called to report that earlier that day, they placed a patient on ecmo.They selected the quantum 27fr dlc, but they were unable to flow.The customer reported that the cannula did prime back with blood, however, when they went to connect the cannula to the cicuit, they were unable to initiate and achieve any flow.Customer reported that the issue appeared to be on the drainage side, as they were not getting blood back to the pump when initiating at 1500 rpms or when slowly increasing rpms.Dr.Reddy, the cannulating surgeon, had to remove this cannula, and over wire to exchange for a different one.They opted to replace our cannula with the 29fr protek duo and were able to successfully drain & flow to the patient.The centrimag console and preconnected pack remained the same, the only change was the cannula.This customer does not monitor pressures on their centrimag pack, so none to report.The customer did save the cannula and would like to send it back for investigation.The coordinator, perfusionist and surgeon all visually inspected the cannula, but did not see anything abnormal.
Additional Manufacturer Narrative
The dlf27-v0 device returned for performance issues.The cannula was visually inspected and then tested to verify its performance.The data collected shows that the device's pressure drops are compliant and in line with the ifu.With the available information, we were unable to identify the cause of the problem linked to the medical device (refer to (b)(4)_investigation_rmd for details).
Event or Problem Description
On friday evening, customer called to report that earlier that day, they placed a patient on ecmo.They selected the quantum 27fr dlc, but they were unable to flow.The customer reported that the cannula did prime back with blood, however, when they went to connect the cannula to the cicuit, they were unable to initiate and achieve any flow.Customer reported that the issue appeared to be on the drainage side, as they were not getting blood back to the pump when initiating at 1500 rpms or when slowly increasing rpms.Dr.Reddy, the cannulating surgeon, had to remove this cannula, and over wire to exchange for a different one.They opted to replace our cannula with the 29fr protek duo and were able to successfully drain & flow to the patient.The centrimag console and preconnected pack remained the same, the only change was the cannula.This customer does not monitor pressures on their centrimag pack, so none to report.The customer did save the cannula and would like to send it back for investigation.The coordinator, perfusionist and surgeon all visually inspected the cannula, but did not see anything abnormal.

• Brand Name: QUANTUM PERFUSION DUAL LUMEN CANNULA DL27
• 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 SRL; 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: 23166422
• Report Number: 3016746283-2025-00009
• Device Sequence Number: 9630239
• Product Code: DWF
• UDI-Device Identifier: 08051160300808
• UDI-Public: (01)08051160300808(17)250831(10)F000838
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/16/2025

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: 08/31/2025
• Device Model Number: DL27F-V0
• Device Lot Number: F000838
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2025
• Supplement Date Received by Manufacturer: 09/02/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown