MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. SECHRIST AIR/OXYGEN, 20112-OBSOLETE-MIXER-TERUMO; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 20112

Device Problems No Audible Alarm (1019); Inaccurate Flow Rate (1249)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

Customer was provided with a return material authorization number to return the mixer for inspection, numerous attempts to the customer have been made for more information or to retrieve the device, but none has been forthcoming.If more information or the device is returned a follow up supplemental report will be sent.Review of the device history for the mixer 20112 (obsolete) found it was manufactured on 08/31/1989.Review of the device history found that the mixer has exceeded the life expectancy of sechrist mixer's which is 20 years provided they are overhauled using sechrist supplied components, as well as sechrist certified technicians, every two years.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.Manufacturer references incident (b)(4).

Event Description

Customer reported that during clinical use, there was a reduction in flow to the patient and the alarm did not go off.They were able to get the patient switched to another mixer right away, so no patient injury.

Manufacturer Narrative

See section b5 for additional information from a medsun mandatory and voluntary report form uf/importer report # 3933020000-2019-8012 received from us department of health and human services on november, 18 2019.Customer report medwatch states they believe the oxygen line on the back of the extracorporeal membrane oxygenation (ecmo) blender (not sechrist device) was loose fitting.This fitting accepts 3/16 tubing and 1/4 tubing, the 3/16 tubing is more secure but the 1/4 tubing was used.Per the customer it is thought that this caused a decrease in oxygenation.Correction to section d.2 product code: dtz addition of information on sections: a2: age 18 days, a3: sex: male, a4: weight: 3 kg.Sechrist industries inc., does not manufature the extracorporeal membrane oxygenation (ecmo) blender and only recommends and sells a 3/16" tubing to be used on the sechrist blender devices.Customer had the sechrist mixer tested by their service provider and it passed all qualitative/quantative tests specifications, no failure found with sechrist air/oxygen mixer.Review of the device history for the mixer 20112 (obsolete) found it was manufactured on 08/31/1989 which indicates the mixer has exceeded the life expectancy of sechrist mixer's which is 20 years provided they are overhauled using sechrist supplied components, as well as sechrist certified technicians, every two years.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.Manufacturer references incident (b)(4).

Event Description

Supplemental medwatch is required for more information received from medsun mandatory and voluntary report form uf/importer report # 3933020000-2019-8012 which provided patient age, weight and gender.More information received on medsun mandatory and voluntary report form states " it is believed that the oxygen line on the back of the extracorppreal membrane oxygenation (ecmo) blender was loose fitting, this fitting accepts 3/16' tubing and 1/4' tubing.The 3/16' is more secure but 1/4' was used.It is thought that this caused a decrease in oxygenation.However, this has been sent to the manufacturer for futher investigation".Note: this ecmo blender is not a sechrist device.Note: sechrist blender model (20112-obsolete) - 3500cp-g, s/n (b)(6) has not been returned to sechrist industries inc., for testing and investigation.

• Brand Name: SECHRIST AIR/OXYGEN, 20112-OBSOLETE-MIXER-TERUMO
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4225 e. la palma ave.; anaheim CA 92807
• MDR Report Key: 9316488
• MDR Text Key: 197769858
• Report Number: 2020676-2019-00021
• Device Sequence Number: 1
• Product Code: DTX
• 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,user facility
• Type of Report: Initial,Followup
• Report Date: 11/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20112
• Device Catalogue Number: 3500CP-G
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXTRACORPOREAL MEMBRANE OXYGENTATION
• Patient Age: 18 DA
• Patient Weight: 3