MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE SET - 125ML, PRODUCT CODE CAC

Model Number CSE-P-125-JA

Device Problem Fluid/Blood Leak (1250)

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

Event Date 04/11/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation of the returned product and photos confirmed the malfunction of inner crack of the bowl.Although there was no serious injury or harm, past reporting indicates this particular malfunction has been associated with a reported death.The investigation of the past report that had a death indicated the inner core leak malfunctioned 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 leak due the confirmed malfunction that occurred.Manufacturing evaluation confirmed inner core crack malfunction.

Event Description

Customer in (b)(6) informed haemonetics the cell saver elite device displayed a long empty error while using a similar device disposable set cell saver elite set - 125ml.There was no report of patient ha.

• Brand Name: CELL SAVER ELITE PLUS AUTOTRANSFUSION SYSTEM
• Type of Device: CELL SAVER ELITE SET - 125ML, PRODUCT CODE CAC
• 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: 11849596
• MDR Text Key: 251771839
• Report Number: 1219343-2021-00021
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016537
• UDI-Public: (01)10812747016537(17)0820066
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K162423
• 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: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2023
• Device Model Number: CSE-P-125-JA
• Device Lot Number: 0820066
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1