MAUDE Adverse Event Report: HAEMONETICS CORP CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM; APPARATUS, AUTOTRANSFUSION

Model Number CSE-E-UK

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reaction (2414)

Event Date 10/10/2017

Event Type  Injury  

Manufacturer Narrative

From the information which is available, there is no evidence that the problems which the patient experienced is related to the operation of the device or the disposable.The device was evaluated by field service engineer on (b)(6) 2017.There were no failures or defects detected on the cell saver® elite® autotransfusion system.The device was tested and found to meet all manufacturing specifications.A functional cycle test was successfully completed.An electrical safety check was passed.There were no problems found during the visit which suggest that the device could have contributed to the patient's condition.

Event Description

On (b)(6) 2017 it was reported to haemonetics that there was an adverse patient reaction following a procedure utilizing the cell saver® elite® autotransfusion system.The patient was well after the procedure, however later that day the patient became unwell.Device was removed from service pending evaluation from a field service engineer.Further information was provided via email on (b)(6) 2017: the patient had a complicated birth and had been complaining of numbness to the face/difficulty to breathe before operation began, not just with administration of cell salvage blood.This indicates the anesthetic block was too high and is what transfusion believe caused the reaction, not the cell salvaged blood.

• Brand Name: CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer (Section G): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer Contact: david ramsay ; 400 wood rd; braintree, MA 02184 ; 7813487327
• MDR Report Key: 6993996
• MDR Text Key: 90796435
• Report Number: 1219343-2017-00032
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CSE-E-UK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention