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 Codes	Disconnection (1171); Device Contamination with Body Fluid (2317)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although there was no serious injury or harm, past reporting (1219343-2021-00013) indicates this particular malfunction on a similar device has been associated with a reported serious injury.The unit was received for evaluation, a visual evaluation was conducted and the tubing from the waste bag was found to be connected to the inlet port of the bowl instead of the outlet port.Root cause has yet to be determined as investigation is still in progress.
Event or Problem Description
On march 11 2021, haemonetics was notified of the tubing from the bowl inlet disconnecting which occurred during a procedure in (b)(6), utilizing the cell saver® 5 autologous recovery system and cell saver® 5 set - 225ml.The procedure was unable to be discontinued as device was contaminated.There was no harm to patient or operator.

• 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: 11646627
• Report Number: 1219343-2021-00108
• Device Sequence Number: 2988181
• 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): 03/11/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/10/2025
• Device Model Number: 00263-00
• Device Lot Number: 0320042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 04/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1