MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER® 5+ AUTOLOGOUS BLOOD RECOVERY SYSTEM; APPARATUS, AUTOTRANSFUSION

Model Number 02005-110-EP

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2018 haemonetics was made aware of a cell saver 5 device which had experienced some extent of thermal decomposition during a procedure as the device operator reported an observation of visible smoke with a burning smell associated.This was reported to have occurred while the device was processing rbcs for a patient.Suncoast perfusion reported that there was no negative health impact to the patient, the rbc loss associated with the procedure was not excessive and did not result in any adverse reaction, injury or negative health decline for the patient.Haemonetics has opened a service ticket to dispatch a field service engineer to evaluate this device.The device evaluation has not yet been completed at this time as the service visit is being coordinated.There has been a delay in granting the field service engineer security clearances to enter the customer's campus facility, at this time the haemonetics service event is pending security clearance permissions from the customer.A follow up report will be submitted once the information from the service visit is available.Haemonetics has previously submitted medwatch reports for incidents of thermal decomposition within a device, as such this incident is deemed reportable.

Event Description

On (b)(6) 2018 haemonetics was made aware of a cell saver 5+ device in which the device operator observed a burning smell and some visible smoke during a procedure.Suncoast perfusion indicated that the device operator did not experience any injuries as a result of the device malfunction.There was no injury or negative health impact as a result of the malfunction during the procedure.The procedure was interrupted, but the associated rbc loss did not result in any adverse reaction or decline in health for the patient.

• Brand Name: CELL SAVER® 5+ AUTOLOGOUS BLOOD RECOVERY SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• Manufacturer Contact: david ramsay ; 400 wood road; braintree, MA 02184 ; 7813487327
• MDR Report Key: 8030284
• MDR Text Key: 126556796
• Report Number: 1219343-2018-00045
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K932890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Administrator/Supervisor
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 02005-110-EP
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2011
• 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