MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM CENTRIFUGAL DRIVE MEDIUM PRESSURE - QCD22; CENTRIFUGAL PUMP DRIVE UNIT

Model Number	QCD22
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that the vv ecmo had suddenly dropped to 1 lpm (coming from 3.5 lpm) without any prior warning.Icu nurses were unable to increase flow at the time of incident.Perfusionist intervened, who was able to restore flow at approx 12:12.Additionally, the cvvh device connected on the circuit alerted for low pressure.It is unsure if this alert is caused by the ecmo low flow, or vice versa.Vitals app does not show any rpm modulation based on either pven or pint/part.
Additional Manufacturer Narrative
The returning of complained device is still ongoing.The investigation conclusions will be included in a follow-up report.
Additional Manufacturer Narrative
Double log investigation showed no technical issues.Therefore, the equipment responded as intended.For this reason, the root cause of the claimed issue can be associated to the human interaction with the system.
Event or Problem Description
User reported that the vv ecmo had suddenly dropped to 1 lpm (coming from 3.5 lpm) without any prior warning.Icu nurses were unable to increase flow at the time of incident.Perfusionist intervened, who was able to restore flow at approx 12:12.Additionally, the cvvh device connected on the circuit alerted for low pressure.It is unsure if this alert is caused by the ecmo low flow, or vice versa.Vitals app does not show any rpm modulation based on either pven or pint/part.

• Brand Name: QUANTUM CENTRIFUGAL DRIVE MEDIUM PRESSURE - QCD22
• Common Device Name: CENTRIFUGAL PUMP DRIVE UNIT
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 24290898
• Report Number: 3006073153-2026-00021
• Device Sequence Number: 9332971
• Product Code: KFM
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K192850
• 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): 02/09/2026

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 Model Number: QCD22
• Device Catalogue Number: 51-000061-00
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown