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

Model Number 60-01-04

Device Problems No Device Output (1435); Pumping Stopped (1503)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin s5 double pump system.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 sorin centrifugal pump 5 (cp5) display went black and the rpm and flow fell to zero during a procedure.The tech support at the facility reported that there was no patient death or serious injury, however the current patient status could not be provided.The customer reported that this issue has occurred before, and the ep pack is suspected to be the cause.A sorin group field service representative was dispatched to the facility to investigate.Serial readouts were performed for several modules, the double roller pump and the cp5.The ep pack was removed from the cp5 and a loan unit was fitted.The unit was functionally tested and no issues were found.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.The replaced ep pack has been requested for return to sorin group (b)(4) for further investigation.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 (cp5) display went black and the rpm and flow fell to zero during a procedure.The tech support at the facility reported that there was no patient death or serious injury, however the current patient status could not be provided.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• 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: carrie wood ; 14401 w 65th.way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5956893
• MDR Text Key: 54944734
• Report Number: 9611109-2016-00606
• 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
• Report Date: 08/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• 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 Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2014
• 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