MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST GAS BLENDER MODEL 3500; MIXER, GENERAL

Model Number 3500CP

Device Problem Medical Gas Supply Problem (2985)

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

Event Date 02/18/2014

Event Type  Injury  

Event Description

Upon initiating cardiopulmonary bypass, the patient was observed to not be receiving oxygen.The room source was checked and the oxygen was being delivered.The source of the defect was the oxygen blender located on the heart-lung machine.The blender was reading as though it was working correctly, but blood gas and observation found the patient was not getting supplemental oxygen.The machine was immediately removed from service.

Manufacturer Narrative

The mfr was made aware of reported failure through a maude event report with the voluntary report number: (b)(4).The following info was received from the hosp.The mixer had just been received back from being serviced by a third party.A performance verification was not completed prior to the mixer being placed into clinical use.Upon placing the patient on bypass, it was immediately noted that the patient's blood was dark, inadequate oxygenation.The patient was removed from the machine and oxygenated manually until another machine was obtained.No alarm activated on the mixer.The mixer was sent a different third party servicing company for overhaul.When the event was reported to the mfr the mixer had already been received back from the third party service company and was placed back into service, per the info provided by the hospital, there was no injury to the patient.The delay in surgery was minimal and the patient is doing fine.Mixer s/n (b)(4) was not returned to the mfr for eval.The mixer was manufactured in october 1984 and is 29 years old.The probable cause for the reported failure is that the device was not properly serviced.

• Brand Name: SECHRIST GAS BLENDER MODEL 3500
• Type of Device: MIXER, GENERAL
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 east la palma ave.; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC.; 4225 east la palma ave.; anaheim CA 92807
• Manufacturer Contact: 4225 east la palma ave.; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 3820008
• MDR Text Key: 4501094
• Report Number: 2020676-2014-00017
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3500CP
• Device Catalogue Number: 3500CP
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2014
• Initial Date FDA Received: 05/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/15/1984
• 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
• Patient Outcome(s): Required Intervention