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

Model Number 60-01-04

Device Problems Device Operational Issue (2914); No Flow (2991); No Pressure (2994)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2016

Event Type  No Answer Provided  

Manufacturer Narrative

On (b)(4) 2016, sorin group received a user medwatch report (mw5064715) regarding this event.However, the user report was filed against the disposable and not the equipment.Please reference medwatch report number 9680841-2016-00503 for information on the disposable.Sorin group (b)(4) manufactures the sorin centrifugal pump 5 (cp5).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 cardioplegia delivery of the sorin centrifugal pump 5 (cp5) lost flow and almost all pressure for about 15 minutes.The entire circuit and heart-lung machine were switched out to continue the procedure.The case was completed without further incident.There was no report of patient injury.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.The investigation is on-going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the cardioplegia delivery of the sorin centrifugal pump 5 (cp5) lost flow and almost all pressure for about 15 minutes.The entire circuit and heart-lung machine were switched out to continue the procedure.The case was completed without further incident.There was no report of patient injury.

• Brand Name: SORIN CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS,
• 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: 6012759
• MDR Text Key: 56973644
• Report Number: 9611109-2016-00707
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-01-04
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/06/2014
• 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