MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND CENTRIFUGALPUMP SCP FOR S5; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-00-50

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

Event Type  No Answer Provided  

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the flow of sorin centrifugal pump system with tubing clamp was low even when the rpms were turned to maximum during a procedure.There was no report of patient injury.The customer reported that the issue has occurred before, and that reorientation of the driver sometimes resolves the issue.Other times the issue has resolved itself after 10-15 minutes.Surgeons have been notified and clamping of the arterial line and cannula have been ruled out by the facility as causes.The customer reported that there is no excessive noise coming from the pumphead to indicate a decoupling.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the flow of sorin centrifugal pump system with tubing clamp was low even when the rpms were turned to maximum during a procedure.There was no report of patient injury.

Manufacturer Narrative

Manufacturer has corrected information for contact and manufacturer.(b)(4) manufactures the livanova centrifugal pump system.The incident occurred in (b)(6).This medwatch report is being filed on behalf of (b)(4).Additional information was received regarding the investigation.The field service rep was unable to reproduce error.He then replaced the flow probe.A functional verification was performed successfully and the unit was placed back into service.The field service rep confirmed that the part replacement in the field was deemed most appropriate.This resolved the problem and there was no need to return the unit for further investigation.Livanova rep investigated on site.

• Brand Name: CENTRIFUGALPUMP SCP FOR S5
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5965390
• MDR Text Key: 55206136
• Report Number: 9611109-2016-00656
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

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: 60-00-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/20/2016
• Supplement Dates Manufacturer Received: 11/17/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2010
• 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
• Patient Age: 63 YR
• Patient Weight: 133