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

Model Number 3500T

Device Problems Device Alarm System (1012); Infusion or Flow Problem (2964)

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

Event Date 03/14/2014

Event Type  malfunction  

Event Description

The customer originally reported that the mixer failed during clinical use.There was "no flow" coming from the device.Further info received from the customer provided the following details: the customer reported that during a cardiopulmonary bypass the pt received low oxygenation.There event occurred immediately when the device went on cardiopulmonary bypass.The mixer was immediately replaced with another unit.There was no delay in the procedure as the exchange took place during the surgery.The pt has since been released from the hospital and is reported as "doing fine".The mixer did not alarm.A downstream alarm and oxygen analyzer were not connected to the device set-up.The mixer was set at 4 liters per minute at 100% fio2.A performance verification was completed prior to the device being placed into clinical use.No issues were found during the performance verification.

Manufacturer Narrative

Eval of the device was completed by the mfr.Visual inspection found that fittings were missing from the water trap and oxygen connector, an extra flow meter was attached to the side of the device and one of the screws is missing from the alarm block.To test the device a test fitting was placed on the oxygen connector.Testing of the mixer found that the proportioning valve would only read 21.2% oxygen and there was no flow output.No further testing could be completed.Upon turning off the gas flow, the 100-1000 ml/min float ball would stick to the top of the flow meter and then drop down.As further testing could not be completed, the mixer was further inspected.The lock nut on the proportioning valve and the check valve on the retainer were found to be loose.Further examination of the proportioning valve found that one of the o-rings appeared to be cut.In addition, the fio2 adjuster needle was turned out too far.Per the customer, the mixer had been overhauled in 02/2014 by a third party.The third party is not recognized by the mfr as having been trained to complete maintenance and/or repairs on the mfr's devices.The root cause for the failure of the mixer is tampering and/or attempted maintenance.The device was not calibrated properly during the overhaul in 02/2014.The root cause for the failure of the float ball in the flow meter is age and/or wear and tear.The flow meter is the original flow meter from time of the mfr and is 26 years old.

• Brand Name: SECHRIST GAS BLENDER MODEL 3500
• Type of Device: MIXER, GENERAL
• Manufacturer (Section D): SECHRIST INDUSTRIES; anaheim CA
• Manufacturer Contact: 4225 east la palma ave.; anaheim, CA 92807 ; 7145798400
• MDR Report Key: 3871271
• MDR Text Key: 4592436
• Report Number: 2020676-2014-00016
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K802226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3500T
• Device Catalogue Number: 3500T
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/1988
• 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
• Patient Age: 61 YR