MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SORIN CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-00-60

Device Problem Pumping Stopped (1503)

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

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

A1-a5: patient information was not provided.D4: the sn is unknown.Therefore the udi is unknown.H4: the sn is unknown.Therefore the manufaturing date is unknown.H10: livanova deutschland manufactures the sorin centrifugal pump 5 (cp5).The incident occurred in usa.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that, during a procedure, the blood flow stopped on the cp5, rpm is still up and no flow.There is no report of any patient injury.

Event Description

See intial report.

Manufacturer Narrative

Livanova field service engineer dispatched to customer's facility found the flow turned off on the control panel but customer could not remember hitting that.No part replacement was needed as no hardware malfunction was confirmed.From the review of the database, no other similar complaints have been submitted on this unit nor from this hospital.Since no problems have been detected during service activity on the cp5 control panel (accordingly no component was substituted) and according to technician, the most likely root cause of the event is a user error.Indeed, it is possible that customer paged over too far while scrolling the menu on the control panel and erroneously hit the flow and set it to "off".No other specific action was currently deemed necessary, livanova maintains and documents periodic customer events monitoring processes in order to evaluate actions for the improvement of the products.Follow up clarified the display was not showing flow rate is always detectable by the user and no pump stop occurred.The event is being reassessed as not reportable since the issue was not a pump stop (flow stopped on the cp5) and it was a sudden stop of the flow sensor to display the flow speed.The issue is promptly detectable and can immediately be addressed by acting on the flow sensor or installing a spare flow sensor.There is no risk of any patient injury.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 19020290
• MDR Text Key: 339133300
• Report Number: 9611109-2024-00167
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/06/2024

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
• Device Operator: Health Professional
• Device Model Number: 60-00-60
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1