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

Model Number 25-60-70

Device Problem Improper Device Output (2953)

Patient Problem No Patient Involvement (2645)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the cp5 flow module.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the cp5 flow module displayed values incorrectly.There was no patient involvement.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group received a report that the cp5 flow module displayed values incorrectly.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the cp5 flow module.The incident occurred in (b)(6).This medwatch report is being filed on behalf of sorin group (b)(4).Sorin group received a report that the cp5 flow module displayed values incorrectly.There was no patient involvement.A sorin group field service representative was dispatched to the facility.The flow module was replaced and returned to sorin group (b)(4) for further investigation.The issue was reproduced after a 30 minute test run.A hardware analysis was conducted, which revealed a faulty pcb board.The faulty board was replaced and a test run of 24 hours was conducted.No further issues were identified.Due to the age of the board, it was determined that no further investigation is required, and the faulty board was discarded.A review of the dhr could not identify any concessions, deviations or nonconformities relevant to the reported failure.This issue will be monitored for trends and if a trend is identified, corrective action will be recommended.

• Brand Name: CP5 FLOW MODULE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr 25; munich, D 809 39; GM D 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: 5168703
• MDR Text Key: 28967096
• Report Number: 9611109-2015-00431
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 09/23/2015

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/23/2015
• Initial Date FDA Received: 10/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2011
• 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