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

Model Number 00263-00

Device Problems Disconnection (1171); Device Contamination with Body Fluid (2317)

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

Event Date 03/10/2021

Event Type  malfunction  

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 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
• 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: 11646627
• MDR Text Key: 246315430
• Report Number: 1219343-2021-00108
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 04/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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