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

Model Number CSE-E-JA

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

Patient Problem Death (1802)

Event Date 09/27/2017

Event Type  Death  

Manufacturer Narrative

There is insufficient clinical evidence that the operation of the cell saver machine contributed to the patient's death.The device was evaluated by haemonetics field services and the device was found to meet all specifications upon evaluation.No fault was observed.The procedure was completed without any alarms, error messages or disposable issues encountered.Bone fragments are a common product of surgical procedures of this nature which can end up in the circulation or collected through cell salvage.The customer confirmed for this particular procedure they were not using the haemonetics sq40s (20 um - 40 um) micro aggregate inline filter.The cell salvage reservoir filter (170 um) can reduce but will not eliminate all fragments released during a procedure.As of march 2018 the customer has implemented use of the haemonetics sq40s micro aggregate inline filter to mitigate possibility of larger particulates being reinfused during transfusion of autologous blood product.

Event Description

On (b)(6) 2018 haemonetics received a report of a patient death that was reported to (b)(4).The procedure and subsequent patient death occurred on (b)(6) 2017.The procedure was completed with no alarms error messages or issues with disposables.The cell saver elite® was in auto mode.The patient died one hour following a plif procedure to treat an ossification of the yellow and posterior longitudinal ligaments.The patient's condition changed suddenly 37 minutes after collected blood was transfused.When a small amount of blood that remained in the collected bag was transfused to the patient was examined, fine bone fragments similar to the specimen of the pathological autopsy were confirmed.At a later date, when blood collected from another patient from a similar procedure was examined, fine bone fragments were also confirmed as a byproduct of the procedure.

• Brand Name: CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): SANMINA; 202 lorong perusahaan maju 9; bukit tengah industrial park; penang, ; MY
• Manufacturer (Section G): SANMINA; 202 lorong perusahaan maju 9; bukit tengah industrial park; penang, ; MY
• Manufacturer Contact: christopher bailey-gates ; 400 wood rd; braintree, MA 02184 ; 7813569845
• MDR Report Key: 7506901
• MDR Text Key: 108003513
• Report Number: 1219343-2018-00009
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: CSE-E-JA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 05/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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
• Patient Outcome(s): Death
• Patient Age: 52 YR
• Patient Weight: 62