MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER 5 AUTOLOGOUS RECOVERY SYSTEM; CELL SAVER 5/5+ BOWL KIT-225ML

Model Number 00263-00

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Blood or Lymphatic problem (4434)

Event Date 02/16/2021

Event Type  Injury  

Manufacturer Narrative

Sample will not be returned to haemonetics for evaluation as sample was discarded immediately.Customer provided photos which did show detachment of tubing but without physical sample haemonetics is unable to determine root cause.

Event Description

On (b)(6) 2021, haemonetics was notified of the connecting tube above centrifuge became detached during a procedure in (b)(6), utilizing the cell saver® 5 autologous recovery system and cell saver® 5 set - 225ml.The procedure was discontinued due to device being contaminated.Blood loss was estimated at 1500ml and patient was in need of a transfusion.There was no harm to patient and operator was wearing ppe.

• Brand Name: CELL SAVER 5 AUTOLOGOUS RECOVERY SYSTEM
• Type of Device: CELL SAVER 5/5+ BOWL KIT-225ML
• 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: 11501542
• MDR Text Key: 240273257
• Report Number: 1219343-2021-00013
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016131
• UDI-Public: (01)10812747016131(17)250310(10)0320042
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K014083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/16/2021

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: Health Professional
• Device Model Number: 00263-00
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/16/2021
• Initial Date FDA Received: 03/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• 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): Other