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

Model Number 60-01-04

Device Problem Electrical Shorting (2926)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the centrifugal pump 5 (cp5).The incident occurred in montreal, canada.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.Livanova initiated an investigation.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 a centrifugal pump 5 (cp5) tripped the circuit breaker of the s5 system e/p pack in use during maintenance.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H.10: the most likely root cause of the reported event is a defective circuit board inside the drive unit which then cause the e/p pack fuse tripping.

Manufacturer Narrative

H.10: the involved part was returned back to manufacturer site for investigation.The reported issue was reproduced and traced back to an incorrect unit assembly, since the electrical connections were seated in the wrong way.After disassembling, re-assembling, disinfecting and performing all the functional tests with positive results, unit was sent back to customer in its expected function.Considering all the above facts, the most likely root cause of the reported event is an incorrect device assembly by user/internal engineering service.

Event Description

See initial report.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 11169388
• MDR Text Key: 226770297
• Report Number: 9611109-2021-00013
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-01-04
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1