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

Model Number 0261J-00

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

No patient information was provided at this time.The bowl from the cell saver® 5 set was returned and evaluated by haemonetics.It was noted during investigation that blood was seen on the inner core.Bowl decompression testing confirmed the blood outflow from the inner core and the outer core welding.

Event Description

On january 20 2020 haemonetics was notified of an inner core leak which appeared on the 2nd cycle of the empty process in (b)(6), utilizing the cell saver® 5 autologous recovery system and cell saver® 5 set - 125 ml.There was no reported impact to patients' health.

• Brand Name: CELL SAVER 5 AUTOLOGOUS RECOVERY SYSTEM
• Type of Device: LOW VOL(125ML) CS5 SET,LN 261J
• 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: 10157978
• MDR Text Key: 195260317
• Report Number: 1219343-2020-00046
• Device Sequence Number: 1
• Product Code: CAC
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/20/2020

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 Expiration Date: 05/01/2024
• Device Model Number: 0261J-00
• Device Lot Number: 0519037
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/20/2020
• Initial Date FDA Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2019
• 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