MAUDE Adverse Event Report: SPECTRUM MEDICAL S.R.L. QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED 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	10/16/2024
Type of Reportable Event	Malfunction
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, no consequences for the patient have been identified.
Event or Problem Description
Has been noted a plasma leakage.During change out and priming the second system were found problems with the pin pressure reading high negatives even though it had been zeroed correctly.Transducers were converted to regular wet transducers.The change out pump head is the same lot number as the one leaking plasma.After they changed it out they kept it and rinsed it for return.
Additional Manufacturer Narrative
The investigation activities were carried out with reference to the plasma leakage event, which is the reason for the current report.For the results of the investigation activities refer to investigation report attached (bgcx0072_investigation_rmd).
Event or Problem Description
Has been noted a plasma leakage.During change out and priming the second system were found problems with the pin pressure reading high negatives even though it had been zeroed correctly.Transducers were converted to regular wet transducers.The change out pump head is the same lot number as the one leaking plasma.After they changed it out they kept it and rinsed it for return.
Additional Manufacturer Narrative
The investigation activities were carried out with reference to the plasma leakage event, which is the reason for the current report.For the results of the investigation activities refer to engineering report attached (er_r&d_cp_24_bgcx0072).
Event or Problem Description
Has been noted a plasma leakage.During change out and priming the second system were found problems with the pin pressure reading high negatives even though it had been zeroed correctly.Transducers were converted to regular wet transducers.The change out pump head is the same lot number as the one leaking plasma.After they changed it out they kept it and rinsed it for return.

• Brand Name: QUANTUM PERFUSION CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED 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 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: 20731611
• Report Number: 3016746283-2024-00006
• Device Sequence Number: 15688607
• Product Code: KFM
• UDI-Device Identifier: 08051160300624
• UDI-Public: 08051160300624
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2025

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: 02/27/2026
• Device Model Number: CP22V-VT
• Device Lot Number: G001256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 10/16/2024; 11/15/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 12/18/2024; 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2024
• 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