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

Model Number CP22V-VT

Device Problem Insufficient Information (3190)

Patient Problem Hemolysis (1886)

Event Date 01/19/2024

Event Type  malfunction  

Manufacturer Narrative

Refer to investigation report attached (b)(4).

Event Description

Patient was showing signs of hemolysis, so the circuit was changed out.The surgeon would like this disposable sent back to italy for investigation.No signs of clot of manufacturer error were otherwise noticed.Patient was not harmed due to change out.

• Brand Name: CENTRIFUGAL BLOOD PUMP CP22 WITH INTEGRATED SENSORS
• Type of Device: 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: 18765906
• MDR Text Key: 336060174
• Report Number: 3016746283-2024-00002
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: CP22V-VT
• Device Lot Number: F000150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1