MAUDE Adverse Event Report: SPECTRUM MEDICAL S.R.L. QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED PRESSURE SENSORS

Model Number	CP22V-VT
Medical Device Problem Codes	Fluid/Blood Leak (1250); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
An ecpr system was found deprimed overnight by an ecmo team member.After confirming all connections to be in good standing- pump head was assessed as large fluid collection found in drive unit housing.Upon inspecting pump head- appears to have hairline crack near the outlet connector which is assumed to be cause.System had previously been primed two days prior and stored inside of locked closet.
Additional Manufacturer Narrative
Additional information related to the event will be available after investigation of returned device, which could be addressed in a follow-up report.Because the problem was detected during the device priming phase, the patient was not involved; moreover, the health effect clinical code assigned represents a worst-case scenario with respect to the present event.
Additional Manufacturer Narrative
For the results of the investigation activities please refer to investigation report attached ("bhcx0487 investigation rmd").Because the problem was detected during the device priming phase, the patient was not involved; moreover, the health effect clinical code assigned represents a worst-case scenario with respect to the present event.
Event or Problem Description
An ecpr system was found deprimed overnight by an ecmo team member.After confirming all connections to be in good standing- pump head was assessed as large fluid collection found in drive unit housing.Upon inspecting pump head- appears to have hairline crack near the outlet connector which is assumed to be cause.System had previously been primed two days prior and stored inside of locked closet.

• Brand Name: QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED PRESSURE SENSORS
• Common Device Name: CENTRIFUGAL BLOOD PUMP
• 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: 22381183
• Report Number: 3016746283-2025-00004
• Device Sequence Number: 18496369
• Product Code: KFM
• UDI-Device Identifier: 08051160300624
• UDI-Public: (01)08051160300624(11)240912(17)260912(10)G001892
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K201320
• 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): 07/23/2025

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 Expiration Date: 09/12/2026
• Device Model Number: CP22V-VT
• Device Lot Number: G001892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 06/03/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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