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

Model Number	00263-00
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Blood or Lymphatic problem (4434)
Date of Event	02/16/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CELL SAVER 5/5+ BOWL KIT-225ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 11501542
• Report Number: 1219343-2021-00013
• Device Sequence Number: 14439400
• Product Code: CAC
• UDI-Device Identifier: 10812747016131
• UDI-Public: (01)10812747016131(17)250310(10)0320042
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K014083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2025
• Device Model Number: 00263-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other