MAUDE Adverse Event Report: CENTURY HLM, LLC CENTURY PERFUSION PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE

Device Problem Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Medtronic received information that when the pump (century perfusion pump, serial number (b)(6)) was turned on it began sounding alarms.It was reset and remained in operating condition.The arterial pump stopped and produced errors e-30, e-22, e-21, etc.After resetting, it continued to exhibit errors.Momentarily perfusion was maintained on the pediatric patient by hand, preserving values within physiological ranges for the patient's condition.Perfusion was resumed with the pump but stopped again presenting errors of sensors and bubbles of first arrest nivel.After that, the pump was left on without any sensor.The computer operation was turned off and left in manual mode.Perfusion was resumed.The case was completed with no patient injury or consequence.The service representative was called and evaluated the pump finding no fault.The next day, the pump was started in the presence of the promex technician and it stopped again.Handcrank was used for 15 minutes.The operator reset the part and stopped perfusion.The patient was removed from bypass.Additional information has been requested on this second case.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CENTURY PERFUSION PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, ROLLER TYPE
• Manufacturer (Section D): CENTURY HLM, LLC
• MDR Report Key: 17528309
• MDR Text Key: 321441103
• Report Number: MW5135240
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2013

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1