MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC. 3500CP-G; RESPIRATORY MIXER

Device Problem Device Operational Issue (2914)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2017

Event Type  malfunction  

Manufacturer Narrative

The unit has not been returned for evaluation.Should the unit be returned and evaluated a follow up report will be submitted.A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue.Mixer 3500cp-g serial number (b)(4) was manufactured on 08/11/2016.There is no indication that there were any relevant discrepancies during manufacturing.

Event Description

It was reported that during use of respiratory mixer during an open heart surgery the arterial blood gas showed low oxygen blood.Customer tried adjusting oxygen but still showed low oxygen blood.Customer swapped mixers and the arterial blood gas was normal.No patient injury was reported.

Manufacturer Narrative

Customer returned mixer 3500cp-g for evaluation.The unit was tested and the following observations were made: the unit's water trap has an indentation in the side of it.The fio2 knob does not engage the double needle valve.The fio2 does not climb higher that 21.1 % o2.The balance baseline reading are out of specification at.30,.60, and.90 fio2.The fio2 knob was checked to see if it has slipped on the shaft.Upon removing the knob there were two (2) distinct marks on the shaft.The shaft was turned to see where the shaft would engage the double needle the adjustment shaft was turned out approximately one (1) turn.The fio2 knob was reinstalled and the unit was retested.The unit when retested with the reset mix fio2 knob tested without any observations.Root cause: the fio2 knob has been reset; there is not enough information to determine by who.Device history review (dhr) was performed.Mixer 3500cp-g serial number (b)(4) was manufactured on 08/11/2016.There is no indication that there were any relevant discrepancies during manufacturing.A review of the device history record (dhr) found no non-conformance that could cause or contribute to the reported issue.

• Brand Name: 3500CP-G
• Type of Device: RESPIRATORY MIXER
• 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: victor arellano ; 4225 e. la palma avenue; anaheim, CA 92807
• MDR Report Key: 6586807
• MDR Text Key: 75817474
• Report Number: 2020676-2017-00010
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K023745
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1