MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND GMBH SORIN CENTRIFUGAL PUMP SYSTEM (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-60

Device Problems No Display/Image (1183); Pumping Stopped (1503); Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2015

Event Type  No Answer Provided  

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump 5.The incident occurred in (b)(6).(b)(4).Sorin group (b)(4) received a report that the sorin centrifugal pump 5 restarted itself during a procedure.There was no report of patient injury.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 sorin centrifugal pump 5 restarted itself during a procedure.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump 5.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 sorin centrifugal pump 5 restarted itself during a procedure.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate but was unable to confirm the reported issue.The complained unit and a serial read-out were returned to sorin group (b)(4) for further investigation.Analysis of the serial read-out at sorin group could not confirm the reported issue.The returned device underwent extensive testing in various configurations and no issues were discovered.A test run of 48 hours did not produce any faults.A review of the dhr did not identify any deviations or non-conformities relevant to the reported failure.Sorin group (b)(4) will continue to monitor this issue for trends.

• Brand Name: SORIN CENTRIFUGAL PUMP SYSTEM (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND GMBH; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GB 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5321311
• MDR Text Key: 34198862
• Report Number: 9611109-2015-00652
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112225
• 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: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-60
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2013
• 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