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 Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On sep 17, 2020, haemonetics manufacturing performed a photo evaluation of the bowl from the low vol(125ml) cs5 set and confirmed a bowl core leak with a crack in the inner core base.Although there was no serious injury or harm, past reporting (1219343-2020-00001-01) indicates this particular malfunction on a similar device has been associated with a reported death event.The investigation of 1219343-2020-00001-01 indicated the inner core of the bowl malfunctioned via a crack but did not cause or contribute to the reported incident according to the surgeon that performed the surgery.Haemonetics decided to conservatively report inner core cracks that are confirmed by manufacturing due the event of the past report.
Event or Problem Description
On august 05, 2020 haemonetics was notified of an inner core leak which was observed during a procedure in (b)(6), utilizing the cell saver 5 autologous blood recovery system and low vol(125ml) cs5 set.There was no reported impact to patients' health.

• 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: 10598623
• Report Number: 1219343-2020-00087
• Device Sequence Number: 3273120
• Product Code: CAC
• UDI-Device Identifier: 10812747016124
• UDI-Public: (01)10812747016124(17)241201(10)1219028
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/01/2024
• Device Model Number: 00261-00
• Device Lot Number: 1219028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1