MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number VKMO 78000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Device requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

"during coronary bypass operation, po2 was measured as 46 at 100% oxygen at blood gas control.The result was confirmed by using a different blood gas measurement device.Ast was 668.The oxygenator has been changed with a new one due to the problem could not been fixed.After replacement, oxygen level was measued as 536 at blood gas control and operation continued.At the end of the operation blood gas checked again, it measued as po2: 344 and ast:614 at 70% oxygen." (b)(4).

Manufacturer Narrative

Field service technician has been sent for investigation and found that the dual pressure module for ch1 & ch2 were bad.According to service order the dual pressure module has been replaced and calibrated.After replacement of all defective part, tests have been performed - system tested ok.The unit incl.All pumps were returned to service upon completion.The defective dual pressure module has been returned for further investigation at manufacturers laboratory/life cycle engineering.According to investigation report the error ¿ep0d¿ could be reproduced (acc.To service manual en02, chapter 9.6.1: ¿stoplogic test failed or error of the stop selection switch.¿).During self-test the "stop-test" failed.Most probable root cause could be determined as defective transistor, which was disturbing the stop signal processing.Thus the failure could be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.

Event Description

(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6770136
• MDR Text Key: 82146056
• Report Number: 8010762-2017-00260
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VKMO 78000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1