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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/27/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CELL SAVER 5/5+ BOWL KIT-225ML
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston, ma
• MDR Report Key: 10198045
• Report Number: 1219343-2020-00053
• Device Sequence Number: 1045380
• Product Code: CAC
• UDI-Device Identifier: 10812747016131
• UDI-Public: (01)10812747016131(17)240728(10)0719076
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K014083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 05/27/2020

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 Model Number: 00263-00
• Device Lot Number: 0719076
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/25/2020
• 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: Other