MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM; LOW VOL(125ML) CS5 SET,LN 261J

Model Number 0261J-00

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

On october 16, 2020 haemonetics manufacturing visually inspected the returned cell saver 5 bowl and confirmed there was blood in the inner core with one (1) crack which resulted in the error the customer received.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 Description

On (b)(6) 2020 haemonetics was notified of a long hour returning message which was displayed during a plastic surgery 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
• Type of Device: LOW VOL(125ML) CS5 SET,LN 261J
• 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: 10704085
• MDR Text Key: 215880853
• Report Number: 1219343-2020-00101
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 10812747016124
• UDI-Public: (01)10812747016124(17)240902(10)0919020
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/16/2020

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
• Device Operator: Health Professional
• Device Model Number: 0261J-00
• Device Lot Number: 0919020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2019
• 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