MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. OXYGEN GAS BLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/14/2020

Event Type  malfunction  

Event Description

Patient with acute drop in saturations and abnormally low po2 on morning abg.Rn also noted sudden minimal color change in ecmo lines.Oxygenator connected to 100% o2 tank by rn with improvement in saturations.Post-oxygenator po2 on tank returned at 169 mmhg.Suspected blender failure (seachrist blender).The blender was exchanged and after about 1 hour of support at 100% fio2 on new blender, post-oxygenator gas re-drawn and it was 249 mmhg.

• Brand Name: OXYGEN GAS BLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e la palma ave; anaheim CA 92807
• MDR Report Key: 10740026
• MDR Text Key: 213196003
• Report Number: 10740026
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23360 DA