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

Model Number 60-02-50

Device Problem Device Issue (2379)

Patient Problem No Patient Involvement (2645)

Event Date 09/14/2015

Event Type  malfunction  

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 received a report that the control knob of the scp control panel became difficult to turn to the right after being rotated all the way left during maintenance.There was not patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the control knob of the scp control panel became difficult to turn to the right after being rotated all the way left during maintenance.There was not patient involvement.

Manufacturer Narrative

(b)(4) manufactures the sorin centrifugal pump system with tubing clamp.The event occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).The device was investigated by a sorin group field service representative and the issue was reproduced.The fault was traced to a loose guide sleeve on the control knob.The service representative repaired the device and returned the unit to service.No further issues have been reported for this unit.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.There is no trend for this type of issue.Sorin group (b)(4) will continue to monitor for trends related to this type of issue.Evaluated by sorin group (b)(4) service.

• 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; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 5154456
• MDR Text Key: 28443837
• Report Number: 9611109-2015-00408
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Followup
• Report Date: 09/17/2015

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: 60-02-50
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2014
• 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