MAUDE Adverse Event Report: BAXTER HEALTHCARE S.A. STYKER FLOW 2; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 250-070-520

Device Problems Corroded (1131); Leak/Splash (1354); Battery Problem (2885); Improper Flow or Infusion (2954)

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

Event Type  malfunction  

Event Description

The stryker suction irrigator was leaking brown/black fluid.This is presumable from the normal salini bag.Somehow the fluid is backing up into the battery compartment and there is corrosion that is dripping from the irrigation pump.Ref: 250-070-520, lot: 22264fg2, exp: 09/20/2024.

• Brand Name: STYKER FLOW 2
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): BAXTER HEALTHCARE S.A.
• MDR Report Key: 15893588
• MDR Text Key: 304695520
• Report Number: MW5113544
• Device Sequence Number: 1
• Product Code: GCX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 250-070-520
• Device Lot Number: 22264FG2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male