MAUDE Adverse Event Report: SPECTRUM MEDICAL S.R.L. QUANTUM PERFUSION DUAL LUMEN CANNULA DL31F-V0

Model Number	DL31F-V0
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	10/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information related to be event available after investigation of the returned device, which could be addressed in a follow-up report.According to available information, there were consequences for the patient that were resolved by surgery.
Event or Problem Description
A cannula go through the rv of a patient.This cannula was placed 7 days prior with no issues.On insertion a small kink was noticed at the insertion site, i informed them to take down the suture and resecure as there was likely too much forward pressure on the cannula.7 days later, the cannula kinked internally and pushed through the rv free wall, requiring the patient to go to surgery.The cannula was removed and the hole was repaired.The patient was then placed on another device.
Event or Problem Description
A cannula go through the rv of a patient.This cannula was placed 7 days prior with no issues.On insertion a small kink was noticed at the insertion site, i informed them to take down the suture and resecure as there was likely too much forward pressure on the cannula.7 days later, the cannula kinked internally and pushed through the rv free wall, requiring the patient to go to surgery.The cannula was removed and the hole was repaired.The patient was then placed on another device.
Additional Manufacturer Narrative
For the results of the investigation activities refer to investigation report attached (b)(4).

• Brand Name: QUANTUM PERFUSION DUAL LUMEN CANNULA DL31F-V0
• 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: 20755721
• Report Number: 3016746283-2024-00005
• Device Sequence Number: 9303048
• Product Code: DWF
• UDI-Device Identifier: 08051160300792
• UDI-Public: 08051160300792
• 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): 02/18/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/30/2025
• Device Model Number: DL31F-V0
• Device Lot Number: F000079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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