MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 3500CP-G

Device Problem Output Problem (3005)

Patient Problems Death (1802); Low Oxygen Saturation (2477)

Event Date 09/05/2019

Event Type  Death  

Manufacturer Narrative

This report is based solely on the reported issue of a death while in use with the sechrist mixer.Additional information was requested to determine the root cause of the failure.At this time, there is no evidence that a manufacturing non-conformity contributed to the reported complaint, and the instructions for use were reviewed and determined to provide adequate instructions and warnings for the safe and effective use of the device.Therefore, no corrective or preventative actions are necessary.All complaints are trended and reviewed by management on a monthly basis.As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted.

Event Description

Distributor reported on behalf of hospital that patient was operated on for a heart transplant on (b)(6) 2019.Patient is labile in terms of blood pressure, hence an increase in norepinephrine and fluids are necessary.At approximately 6:30 pm, the ecmo "goes wrong" with the map falling below 60, the doctor is called, filling on the ecmo.Then the blood pressure sharply drops to 40 of map.The doctor arrives immediately and does an ultrasound, patient filled by pvc and increase in noradrenaline; o2vs falls.The staff notice that the scanning is decreased (3 initially the registered nurse did not turn the knob and performed the ecmo monitoring at 6:15 pm) and that the ecmo cannulas were dark and with no marked visible difference.Doctors notice that the scanning adjustment knob is sensitive.During this time adrenaline and fluids are continued.The patient stabilizes around 6:50 pm with correct saturation and map.Patient died on (b)(6) 2019.The analysis of the causes is in progress.

Manufacturer Narrative

Additional information received from the distributor who later reports that they learned about the death of a patient following a problem with a sechrist gas blender (s/n: (b)(4)).According to initial reports, after using a scpc ecmo last thursday, users found that there was no oxygen to feed the patient.Testing of the returned device did not confirm the reported issue of mixer having no oxygen.Mixer was found when tested that the alarm calibration on the mixer was out of sechrist specifications.Balance regulator test failed at the two settings,.60 fio2 at 60 psi air and 40 psi oxygen and.90 fio2 at 60 psi air and 40 psi oxygen.Balance regulator also failed for accuracy at.30 fio2.Visual inspection found that non-sechrist fittings were used for the quick disconnects which are specific to oxygen and air connections.The alarm adjuster stop nuts are not sechrist parts (these parts are silver in color, whereas the sechrist parts are brass) and the flow meter knobs are not sechrist parts.The build and manufacturer label has been removed, the sechrist warning label is missing, review of the service records for this device (sn# (b)(4) mfg.Date 3/28/2005) showed the unit was not calibrated by sechrist.Functional test of the returned sechrist mixer show the unit is not functioning as expected.Manufacturer references incident (b)(4).

Event Description

More information provided by the user facility where the event occured states that on (b)(6) 2019 patient arrived in intensive care after a heart transplant, and av ecmo set to 3 l/min of sweeping fi02 @ 50 % and 2000 rpm.At around 6 pm, hypotension and svo 2 drop on the swann ganz was reported to the referring doctor by the nurse in charge of the patient.The nurse in turn monitors the parameters on the scope and av ecmo (2000 rpm sweeping at 3 l/min fi02 z 50 %) on (b)(6) 2019 the health professional reports that the av ecmo: sweeping at 8 l/m, fi02 at 100 %.On (b)(6) 2019 patient passed away from encephalic death.

• Brand Name: SECHRIST AIR/OXYGEN MIXER, MODEL 3500CP-G
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• MDR Report Key: 9168739
• MDR Text Key: 161656476
• Report Number: 2020676-2019-00018
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3500CP-G
• Device Catalogue Number: 3500CP-G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Date Manufacturer Received: 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ECMO MONITORING SYSTEM.
• Patient Outcome(s): Death