MAUDE Adverse Event Report: HAEMONETICS CORPORATION CELL SAVER ELITE/RESERVOIR,HARDSHELL,150 U

Catalog Number 00205-00

Device Problem Material Integrity Problem (2978)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

Lot #0322081 was manufactured according to approved procedures and met all specifications for release, with no noted manufacturing deviations, nonconformances or capas that would have contributed to the reported incident.There were no recalls or adverse trends related to the product lot used in the procedure.The complaint investigation is on-going.There was no reported adverse event associated with the patient.

Event Description

On september 16, 2022, haemonetics was notified of an issue during a procedure using a 150u hardshell reservoir on a cell saver elite system.The customer reported a plastic part in the reservoir was stuck in the drain to the connecting shaft to the pipe of the bowl.Patient blood was not washed and not reinfused but preserved blood from the blood bank used instead.There was no reported patient adverse event.The decision was made to report this event as a product problem due to a potential delay to procedure.

Manufacturer Narrative

As part of the complaint investigation, a photograph provided by the customer was evaluated and the "injection gate" was observed to have been detached.Testing was performed using the ultrasonic welder, however, the defect could not be replicated.The injection gate may have had a molding defect which could have caused it to become loose from vibrations of the welding process of another part during assembly.This is the first instance of this issue being reported from the field involving this lot.Corrective action was taken to reinforce current inspection activities via a quality alert posted in manufacturing areas notifying inspectors to be aware of this issue.Updated information: b.4, g.6, h.2, h.6.

• Brand Name: CELL SAVER ELITE/RESERVOIR,HARDSHELL,150 U
• Type of Device: CELL SAVER ELITE/RESERVOIR,HARDSHELL,150 U
• 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: 15586507
• MDR Text Key: 307155626
• Report Number: 1219343-2022-00044
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K162423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00205-00
• Device Lot Number: 0322081
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2022
• 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
• Patient Outcome(s): Hospitalization