MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3500B- OBSOLETE-MIXER, BAXTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 3500B

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

Manufacturer evaluation results: the mixer was received and was found to be out of specification when tested the unit ranges from plus 1.5 above the set value to minus 2.7 below the set value at.30 and 1.00 fi02 respectively.The reason for the failure is device is out of calibration.The device history record review found the mixer was manufactured in 1985 and no indication in the manufacturing of any non-conformances that could cause or contribute to the reported issue.User's manual states: the sechrist air/oxygen mixer is a "precision pressure regulation and proportioning device, which is designed to accurately mix medical grade air and medical grade oxygen (02).Prior to each clinical usage, the user should perform an alarm test and analyze the full fio2 range.With an accurately calibrated oxygen analyzer, the user should analyze the fio2 at the following settings; 21%, 40%, 60%, 80%, and 100%.Additionally, the user should briefly disconnect one supply gas to assure that the bypass/alarm system is functioning.With a single supply gas disconnected, the audible alarm should sound and the analyzed fio2 should indicate the fio2 of the single supply gas; i.E.21% if the oxygen was disconnected and 100% if the air supply was disconnected.

Event Description

During clinical use, customer found that o2 was not delivering appropriate amount ("was way under delivering), o2 was being monitored by staff and they immediately switched mixers.Mixer was removed from service.Patient was not injured.Clinical engineering tested unit at 100% and unit was only delivering 80%.Tested at 60% and was delivering 40%.Patient was not injured.

• Brand Name: 3500B- OBSOLETE-MIXER, BAXTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC.; 4224 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 ; 7145798309
• MDR Report Key: 8895435
• MDR Text Key: 216230639
• Report Number: 2020676-2019-00012
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3500B
• Device Catalogue Number: 3500B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2019
• Initial Date FDA Received: 08/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1