MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND STOCKERT S5 SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 48-50-00

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

Patient Problem Hematuria (2558)

Event Date 09/15/2013

Event Type  Other  

Event Description

Sorin group (b)(4) received a report that the arterial and suction pumps of the stockert s5 system seemed to be over occluded during a procedure and resulted in hemolysis.It was communicated that the pt experienced post-operative hematuria.

Manufacturer Narrative

The device manufacture date will be provided in the f/u report.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 (b)(4) received a report that the arterial and suction pumps of the stockert s5 system seemed to be over occluded during a procedure and resulted in hemolysis.It was communicated that the pt experienced post-operative hematuria.The customer reported that measurements of the occlusion roundness found both pumps to be out of tolerance.The investigation is ongoing.A f/u report will be sent when the investigation is complete.

• Brand Name: STOCKERT S5 SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• 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: 3592692
• MDR Text Key: 4164440
• Report Number: 1718850-2013-00320
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K080832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/15/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 48-50-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 6 YR