MAUDE Adverse Event Report: HAEMONETICS CORPORATION BASIC HI SPEED CS5 SET,LN 263J

Model Number 0263J-00

Device Problem Material Integrity Problem (2978)

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

Event Date 11/18/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, haemonetics was notified of an inner core leak on the bowl of the cell saver® 5+ basic hi speed cs5 set.Investigation findings confirmed an inner core crack of the bowl on (b)(6) 2022.There was no report of harm to the patient.

Manufacturer Narrative

On (b)(6) 2022, haemonetics investigation findings of the received bowl from the cell saver® 5+ basic hi speed cs5 set confirmed blood in the inner core with a crack in the inner core base.Although there was no serious injury or patient 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 to the event of the past report.

• Brand Name: BASIC HI SPEED CS5 SET,LN 263J
• Type of Device: BASIC HI SPEED CS5 SET,LN 263J
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: brenda bruyere ; 125 summer street; boston, MA 02110
• MDR Report Key: 15987211
• MDR Text Key: 308190835
• Report Number: 1219343-2022-00057
• 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,Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0263J-00
• Device Lot Number: 1021023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1