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

Model Number 25-60-70

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

Patient Problem No Patient involvement (2648)

Event Date 06/23/2014

Event Type  Other  

Event Description

Sorin group received a report that s5/c5 sensor module did not function during set-up.There was no patient involvement.

Manufacturer Narrative

There was no patient involvement.Sorin group (b)(4) manufactures the s5/c5 sensor module.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that s5/c5 sensor module did not function during set-up.There was no patient involvement.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; munich D 80 939; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 80 939; GM D 80939
• Manufacturer Contact: cheri voorhees, mgr ; 14401 west 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 3952356
• MDR Text Key: 18034131
• Report Number: 1718850-2014-00231
• 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: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/23/2014

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: 25-60-70
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/23/2014
• Initial Date FDA Received: 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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