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.

• 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
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC.; 4225 e. la palma avenue; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 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
• Reporter Country Code: IT
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Biomedical Engineer
• 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

• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2005
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 10/08/2019 Patient Sequence Number: 1