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

Model Number	00261-00
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Blood or Lymphatic problem (4434)
Date of Event	01/05/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CELL SAVER 5/5+ BOWL KIT-125ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• MDR Report Key: 11278294
• Report Number: 1219343-2021-00003
• Device Sequence Number: 16791914
• Product Code: CAC
• UDI-Device Identifier: 10812747016124
• UDI-Public: (01)10812747016124(17)220109(10)0117047
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 01/06/2021

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: 01/09/2022
• Device Model Number: 00261-00
• Device Lot Number: 0117047
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 02/04/2021
• 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: Life Threatening