MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND CP5 FLOW PROBE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 25-60-70

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the cp5 flow probe.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the issue occurred once during setup and once during the procedure.The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the cp5 displayed a non-zero flow rate when there was no flow.It was reported that the issue occurred once during setup and once during the procedure.There was no report of injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the cp5 flow probe.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group received a report that the cp5 displayed a non-zero flow rate when there was no flow.It was reported that the issue occurred once during setup and once during the procedure.There was no report of injury.The involved unit was returned to sorin group (b)(4) for further investigation.A visual inspection and hardware analysis were performed, and the reported issue was reproduced and the issue was localized to a faulty board.The flow board was replaced and a test run of 24 hours revealed no further issues.An informative supplier quality notification was issued to the manufacturer to make them aware of this incident.The device was scrapped following the investigation.A review of the dhr could not identify any concessions, deviations and nonconformities relevant to the reported failure.No trends have been identified.The market will be monitored for trends related to this issue.

• Brand Name: CP5 FLOW PROBE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND ; lindbergh strasse 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND GMBH; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: carrie wood ; 14401 w. 65th way; arvada, CO 80004 ; 3034676461
• MDR Report Key: 5060815
• MDR Text Key: 25292168
• Report Number: 9611109-2015-00355
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• 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
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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