MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-01-00

Device Problem Device Issue (2379)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the centrifugal pump.The incident occurred in (b)(6).This report is filed on behalf of sorin group (b)(4).Sorin group received a report that the centrifugal pump displayed an error code during set-up.There was no patient involvement.The investigation is on-going.A follow-up will be submitted when the investigation is complete.

Event Description

Sorin group received a report that the centrifugal pump displayed an error code during set-up.There was no patient involvement.

Manufacturer Narrative

The initial submission of follow-up #1 on june 21, 2017 referenced the incorrect mfr number (961109) instead of livanova (b)(4) mfr number 9611109.The submission passed cdrh, so notification to void that occurrence will be submitted through the help desk.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(6).The drive unit of the centrifugal pump system with tubing clamp was returned to livanova (b)(4) for further investigation.Visual inspection did not identify any abnormalities or defects.Functional testing and a hardware analysis identified the root cause for the reported issue to be a defective hall sensor on the circuit board of the stator.The stator with circuit board were replaced on the device.Subsequent functional testing found no further issues.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

Manufacturer Narrative

Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(4).This medwatch report is being filed on behalf of livanova deutschland.The s5 roller pump was returned to livanova deutschland for further investigation.Visual inspection did not identify any abnormalities or defects.Functional testing and a hardware analysis could not reproduce the reported issue.The concentricity of the pump head and the symmetry of the occlusion were measured and confirmed to be within tolerance.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.As per e-mail from (b)(4) dated 9 feb 2021 livanova is submitting this follow-up in replacement of the already provided medwatch 9611109-2015-441 due to the fact that the reference provided was incorrect.

Event Description

See initial report submitted outside of reliance (mfr 9611109-2015-00380).

• Brand Name: SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; d 80939 munich,
• MDR Report Key: 5098838
• MDR Text Key: 26599755
• Report Number: 9611109-2015-00380
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K062396
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Followup,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-01-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/22/2017
• Patient Sequence Number: 1