MAUDE Adverse Event Report: HAEMONETICS CORP. CELL SAVER ELITE

Catalog Number CSE-E-US

Device Problems Failure to Power Up (1476); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 11/02/2014

Event Type  Death  

Event Description

Haemonetics product support received a call on (b)(6) 2014 from a customer stating that while they were utilizing the cell saver elite device, they received error code (line sensor not detecting fluid when expected), and that cleaning the line sensor did not resolve the issue.The customer later called back on (b)(6) 2014 and indicated a pt death was involved in a case on (b)(6) 2014 and during the incident caller indicated the operator could not get the shed blood to process and some clots were seen in the reservoir.An event code, fluid not detected when expected, preceded the line sensor event code.The customer had called in a previous complaint on the same device on (b)(6) 2014 for the issue of a power supply failure.The device was still in use.A haemonetics field service engineer evaluated the device on (b)(6) 2014.There was no problem found.A functional test was run with no issues and the device met mfr specifications.The driver pcb was replaced as a precaution to address the reported power supply issue from (b)(6) 2014.The device was put back in service.

• Brand Name: CELL SAVER ELITE
• Manufacturer (Section D): HAEMONETICS CORP.; 400 wood rd.; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd.; braintree, MA 02184 ; 7819170643
• MDR Report Key: 4307428
• MDR Text Key: 5273483
• Report Number: 1219343-2014-00027
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CSE-E-US
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/08/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death