MAUDE Adverse Event Report: SECHRIST INDUSTRIES, INC 3500CP-G LOW FLOW; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS, PRODUCT CODE: DTX

Model Number 3500CP-G

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

This report is based solely on the customer reported issue.The device was requested to be returned and has not been received by the manufacturer for evaluation.Review of dhr 3500cp-g mixer sn (b)(4) (manufactured 09/01/1987) found no indication that there were any relevant discrepancies during manufacture of the device and no non-conformance that could have caused or contributed to the reported issue; the device passed all product verification testing and met specifications when shipped.Based on the age of the device, it is unlikely that a manufacturing non-conformance contributed to the reported issue.The instructions for use state "in order to assure proper function and accuracy, the sechrist air/oxygen mixers must be thoroughly overhauled every two- (2) years.To maintain the product warranty, this overhaul must be performed by sechrist industries or by sechrist authorized personnel.The lifetime of sechrist air/oxygen mixers is 20 years provided they are overhauled using sechrist supplied components and sechrist certified technicians once every 2 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 reference file # (b)(4).

Event Description

Customer reported during use, it was found that there was no color change (on the o2 analyzer).Hospital increased o2 and there was no change.Hospital then switched out with another blender.No patient injury was reported.

• Brand Name: 3500CP-G LOW FLOW
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS, PRODUCT CODE: DTX
• Manufacturer (Section D): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer (Section G): SECHRIST INDUSTRIES, INC; 4225 e. la palma ave.; anaheim CA 92807
• Manufacturer Contact: majid mashayekh ; 4225 e. la palma ave.; anaheim, CA 92807 ; 7145798309
• MDR Report Key: 10653628
• MDR Text Key: 249814778
• Report Number: 2020676-2020-00014
• Device Sequence Number: 1
• Product Code: DTX
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/1987
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1