MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-15

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 02/16/2015

Event Type  Other  

Event Description

Sorin group (b)(4) rec'd a report that, upon initiating bypass, the user was unable to establish flow from the centrifugal pump.There was no report of pt injury.

Manufacturer Narrative

Sorin group (b)(4) mfg the centrifugal pump sys with tubing clamp (scp).The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group rec'd a report that, upon initiating bypass, the user was unable to establish flow from the centrifugal pump.There was no report of pt injury.The investigation is ongoing.A f/u report will be sent when the investigation is complete.

Manufacturer Narrative

(b)(4).Sorin group (b)(4) received a report that, upon initiating bypass, the user was unable to establish flow from the centrifugal pump.The sorin service representative could not reproduce the error.The device was inspected and the internal connectors were reseated.No re-occurrence has been received since this action.The device worked as specified.It was noted that corrosion was found at the base of the scp control panel, but not on any pins.The customer was recommended to replace the flow board as a precaution.No nonconformities were noted during the device history record review regarding this issue.The issue will be monitored for trends and if identified, corrections will be recommended.

• Brand Name: SORIN CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• 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 D 809 39; GM D 80939
• Manufacturer Contact: cheri voorhees, mgr ; 14401 w 65th way; arvada, CO 80004 ; 3034676527
• MDR Report Key: 4649725
• MDR Text Key: 5684208
• Report Number: 9611109-2015-00066
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2015

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: 60-02-15
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2015
• Initial Date FDA Received: 03/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• 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