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

Model Number 60-02-60

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/04/2014

Event Type  Other  

Event Description

Sorin group received a report that the audio alarm on the cp5 sometimes did not sound when the visual alarm was displayed.The problem was intermittent.There was no report of patient injury.

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump 5.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 audio alarm on the cp5 sometimes did not sound when the visual alarm was displayed.The problem was intermittent.There was no report of patient injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.

Manufacturer Narrative

Sorin group (b)(4) manufactures the sorin centrifugal pump 5.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 audio alarm on the cp5 sometimes did not sound when the visual alarm was displayed.The problem was intermittent.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate.While at the facility, the service representative replaced the involved cp5 control panel, updated the system software and performed preventive maintenance.The replaced cp5 control panel was returned to sorin group (b)(4) for evaluation.Evaluation of the returned device was unable to reproduce the reported issue.The device performed as expected and no problems were found.A review of the dhr could not identify any concessions, deviations and nonconformities relevant to the reported failure.Without the ability to reproduce the reported issue, the root cause could not be determined.No trend has been identified.Sorin group (b)(4) will continue to monitor the market for trends related to this issue.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CARDIOPULMONARY BYPASS PUMP SPEED CONTROL
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 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: 4054744
• MDR Text Key: 19803907
• Report Number: 1718850-2014-00325
• 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,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• 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