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

Model Number 60-00-60

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Patient involvement (2648)

Event Date 09/30/2013

Event Type  Other  

Event Description

Sorin group received a report that during pre-operation set-up, the system pump head was rotating erratically and did not maintain rotations.The machine was not used for the case.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the stockert s5 system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that during pre-operation set-up, the system pump head was rotating erratically and did not maintain rotations.The machine was not used for the case.There was no pt involvement.A sorin group field service rep was dispatched to the facility to investigate.While at the facility, the service rep checked all connections as well as the operation of the equipment and everything was found to be functioning properly.It was also reported that the sorin equipment was being used with an adapter and disposable from another manufacturer.No modifications were tested and approved by sorin group (b)(4) for this facility for the use of the other mfr's adapter and disposable with the cp5.Sorin group has requested that the sorin equipment be returned for eval.To date no product has been returned.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CARDIOPULMONARY BYPASS PUMP SPEED CONTROL
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; arvada CO 80004
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; arvada CO 80004
• Manufacturer Contact: cheri voorhees, mgr ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3780794
• MDR Text Key: 4443004
• Report Number: 1718850-2014-00108
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-00-60
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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