MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM; CS ELITE FASTPACK,125ML,150U

Model Number CSE-FP-125V

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2021

Event Type  malfunction  

Manufacturer Narrative

On december 08, 2021 haemonetics manufacturing performed a visual inspection of the received bowl from the cell saver® elite fastpack - 125ml and confirmed blood in the inner core with cracks in the inner core base.Although there was no serious injury or harm, past reporting (1219343-2020-00001-01) indicates this particular malfunction on a similar device has been associated with a reported death event.The investigation of 1219343-2020-00001-01 indicated the inner core of the bowl malfunctioned via a crack but did not cause or contribute to the reported incident according to the surgeon that performed the surgery.Haemonetics decided to conservatively report inner core cracks that are confirmed by manufacturing due the event of the past report.

Event Description

On december 08, 2021, haemonetics was notified of a fractured latham bowl and leaked blood in the inner cavity during a procedure in (b)(6), utilizing the cell saver® elite® autotransfusion system and cell saver® elite fastpack - 125ml.There was no reported impact to patients' health.

• Brand Name: CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM
• Type of Device: CS ELITE FASTPACK,125ML,150U
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 13002180
• MDR Text Key: 285827017
• Report Number: 1219343-2021-00154
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)240709(10)0721017
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K120586
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSE-FP-125V
• Device Lot Number: 0721017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2021
• 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