MAUDE Adverse Event Report: SORIN GROUP INC SORIN REVOLUTION CENTRIFUGAL PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Lot Number 60509416

Device Problem Insufficient Information (3190)

Patient Problems Hemolysis (1886); Rash (2033)

Event Date 08/16/2015

Event Type  malfunction  

Event Description

Faint lacy, reticular rash started developing; by the fourth day, the rash was very severe and prominent on the patient's right shoulder and flank.Plasma hemoglobin commonly around 50; peak was 170 prior to rash progressing.Circuit change resulted in improvement in rash and lowering of plasma free hemoglobin.It is unclear if the device caused or contributed to the development of the rash/hemolysis.

• Brand Name: SORIN REVOLUTION CENTRIFUGAL PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): SORIN GROUP INC; 14401 west 65th way; arvada, CO 80004
• MDR Report Key: 5060191
• MDR Text Key: 25114553
• Report Number: 5060191
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 08/28/2015,09/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Lot Number: 60509416
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 3