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

Model Number 00263-00

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 05/27/2020

Event Type  Injury  

Manufacturer Narrative

No patient information was provided at this time.A photo was provided of the bowl from the cell saver® 5 set which one could observe that a leak has occurred.The bowl has yet to be returned and evaluated by haemonetics.Without physical sample provided for evaluation the root cause could not be determined.

Event Description

On may 27 2020 haemonetics was notified of an adverse event which occurred on the 1st cycle of the process phase during a procedure in (b)(6), utilizing the cell saver® 5 autologous recovery system and cell saver® 5 set - 225ml.A total of 800ml of blood was lost, procedure was stopped immediately and allogeneic blood was transferred to patient.There was no reported impact to patients' health.

• 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
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• Manufacturer Contact: janice kiser ; 125 summer street; boston, ma
• MDR Report Key: 10198045
• MDR Text Key: 197968383
• Report Number: 1219343-2020-00053
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016131
• UDI-Public: (01)10812747016131(17)240728(10)0719076
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K014083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00263-00
• Device Lot Number: 0719076
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other