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

Model Number CSE-P-225

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

Based upon the clinical information available it is not possible to determine whether the patient's critical condition was due in part or in entirety as a result of the leaking disposable bowls.The bowls were returned for evaluation, a visual inspection confirmed the presence of cracks along the base of the bowl.The base diameter of the bowl was measured on each unit, all four units were found to meet dimensional specifications.The bowls were installed into a centrifuge chuck without problem.Submersion leak testing was performed, and a leak was confirmed in three of the four returned bowls.A root cause of the bowl failure has not been established at this time, it is not possible to determine at which point during the product lifecycle the cracks developed along the bowl weld, it is possible that the bowls were damaged at some point after being released from manufacturing prior to use, either during product handling while shipping or during product handling during installation and procedure setup.Haemonetics attempted to reproduce the failure mode for cracks forming along the base weld of the bowl as well as for a leak at the base weld, it was not possible to reproduce the damages observed in the returned samples through the manufacturing process.The manufacturing process employs a 100% dynamic leak test for these products, the gross leaks found on the returned products would have been detected during the dynamic leak test.The damages which resulted with leaking products were not caused by any observable error or deviation in the manufacturing process.

Event Description

The event occurred (b)(6) 2017 during a surgical procedure to repair an abdominal aortic aneurysm.The patient required multiple units of rbcs during the surgery and post op due to leakage of disposable bowls into the well of the cell saver machine which prompted a shutdown of the machine.This occurred with three separate machines.The disposables appeared to have a leak at the bottom of the bowl.As each machine became disabled, another system was set up with a new disposable.The problem kept repeating until all machines were not functional and 5 liters of blood collected in a reservoir that was unable to be processed.A belmont rapid infuser was used with bank blood to replace the blood loss.

• Brand Name: CELL SAVER® ELITE® AUTOTRANSFUSION SYSTEM
• Type of Device: CELL SAVER ELITE
• 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: 6797647
• MDR Text Key: 82795329
• Report Number: 1219343-2017-00016
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016544
• UDI-Public: (01)10812747016544(17)200411(10)0417067
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2017

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: Other
• Device Expiration Date: 04/11/2020
• Device Model Number: CSE-P-225
• Device Catalogue Number: CSE-P-225
• Device Lot Number: 0417067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/19/2017
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 88