MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE AUTOTRANSFUSION SYSTEM; CELL SAVER ELITE SET - 225ML

Model Number CSE-P-225-JA

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/17/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information was provided at this time.A photo was provided of the bowl from the cell saver elite set which confirmed a leakage at the top header shield ports of the bowl.The bowl is not available for return.Without physical sample provided for evaluation the root cause could not be determined.

Event Description

On (b)(6) 2020 haemonetics was notified of a fluid eruption which had occurred during a spinal procedure, utilizing the cell saver® elite® autotransfusion system and cell saver® elite set - 225ml.There was no reported impact to patients' health and no possible exposure to the techs involved in cleaning the system.

• Brand Name: CELL SAVER ELITE AUTOTRANSFUSION SYSTEM
• Type of Device: CELL SAVER ELITE SET - 225ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: janice kiser ; 125 summer street; boston, ma
• MDR Report Key: 10293479
• MDR Text Key: 201510578
• Report Number: 1219343-2020-00069
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 30812747016357
• UDI-Public: (01)30812747016357
• 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: foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSE-P-225-JA
• Device Lot Number: 0919053
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/23/2012
• 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