MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH CP5 FLOW MODULE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 25-60-70

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 05/30/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information were not provided.H10: livanova deutschland manufactures the flow sensor measurement.The incident occurred in united states.A livanova field service engeneet was dispatched to the customer and found the flow sensor and the flow module were out of tolerance.They have been replaced.Performed flow test performance passed.Performed all functional checks per tsi system is functional and ready for use.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland has received a report that, during a procedure, patient blood flow will not correlate when the rpm maxs out.There was no patient injury.

Manufacturer Narrative

H10: complaints database analysis revealed no similar event since unit installation in 2019.It cannot be ruled out that the root cause of the reported event was a defective flow sensor and module due to wear.

• Brand Name: CP5 FLOW MODULE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17225143
• MDR Text Key: 318224288
• Report Number: 9611109-2023-00293
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 04033817900733
• UDI-Public: (01)04033817900733(11)190401
• 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,Followup
• Report Date: 06/29/2023

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: 25-60-70
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/29/2023
• Supplement Dates Manufacturer Received: 07/28/2023
• Supplement Dates FDA Received: 08/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1