MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM; CELL SAVER 5/5+ BOWL KIT-125ML

Model Number 00261-00

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Blood or Lymphatic problem (4434)

Event Date 01/05/2021

Event Type  Injury  

Manufacturer Narrative

Haemonetics sent a field service engineer to evaluate the cell saver 5 autologous blood recovery system.There were no issues noted with the equipment.Sample will not be sent to haemonetics for evaluation, set was discarded.Without a sample provided for manufacturer evaluation the root cause cannot be determined.

Event Description

On january 06, 2021, haemonetics was notified of a bowl leak which occurred during a procedure in (b)(6), utilizing the cell saver 5 autologous blood recovery system and low vol(125ml) cs5 set.An error code of 21 and 24 was displayed during procedure.There was a blood loss reported of 800ml with the first low vol(125ml) cs5 set utilized then 300ml of blood lost with the second low vol(125ml) cs5 set of the same lot.Due to the amount of blood loss a blood transfusion was necessary.

• Brand Name: CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM
• Type of Device: CELL SAVER 5/5+ BOWL KIT-125ML
• 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: 11278294
• MDR Text Key: 230241722
• Report Number: 1219343-2021-00003
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016124
• UDI-Public: (01)10812747016124(17)220109(10)0117047
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: 00261-00
• Device Lot Number: 0117047
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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): Life Threatening