MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SORIN S5 CENTRIFUGAL PUMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-60

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

Event Date 04/19/2024

Event Type  Injury  

Event Description

Centrifugal pump failure prior to cpb.A statement by (b)(6), who was pumping the case: "on (b)(6) 2024 i was at (b)(6) starting a cabg with dr.(b)(6).Before the case started, i went through my checklist with no issues.Once the lines were connected to the patient, i started rapping my lines around 0930.I noticed the pressure dropping towards the end of my rap and went to transfuse the patient volume when suddenly, the pump head stopped working.I immediately told the surgeon the issue and clamped my lines to troubleshoot the issue.The nurse called (b)(6) around that time and notified him about the issue.The cp5 console had a red banner and the alarm cent pump 1 with rpms still on at around 1500.I noticed that it was not actually flowing.I started by turning off the cp5 console and back on, still alarmed.I also turned my rpms to 0, disconnected the pump head and reconnected it, still alarmed.About ten minutes later with no further intervention, the alarm just suddenly disappeared, and the pump was working again.We still decided it was best to change out the pump and pump head from the disposable, which (b)(6) and i did at around 0950.Once changed out, we tested the new pump and recirculated the blood for a few minutes as well as flashed the lines connected to the patient.We agreed the pump was ready to be used and went on cpb at 1029.No further issues had happened since then." the serial number for the liva nova cp5 control unit (ref 60-02-60) is (b)(6).The sn for the motor (ref 60-01-04) is (b)(6).The pump base is 48-30-00 sn:(b)(6).The terumo centrifugal head is (b)(6).No harm occurred to the patient and 50ml of blood was lost.Biomed notified, liva nova notified, and terumo notified.

• Brand Name: SORIN S5 CENTRIFUGAL PUMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH
• MDR Report Key: 19173911
• MDR Text Key: 341075905
• Report Number: MW5154158
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/19/2024

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
• Device Operator: Health Professional
• Device Model Number: 60-02-60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: THE MOTOR, PUMP BASE AND TERUMO CENTRIFUGAL HEAD.
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Race: White