MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/ SOFTLINE COATING

Model Number VKMO 70000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 07/16/2015

Event Type  Death  

Manufacturer Narrative

Maquet cardiopulmonary ag requested the product back for investigation.Product was received on 08/11/2015.Investigation is still pending.A supplemental medwatch will be submitted as soon as further info becomes available.Abbreviations: ecmo = extracorporeal membrane oxygenation.Act = activated clotting time.Icu = intensive care unit.The product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-i which is registered under 510 (k): k082117.

Event Description

Description from the customer report: "after about 3hrs later from the beginning operation, big pressure difference between before and after-oxygenator like oxygenator seems to be clogged.So replaced with a new oxygenator.But the pt is not good.Perfusionist say that clog by blood is very low because of act value is no high." additional info: pt died about 15hrs later after transferring to icu.Except of old age, no special clinical condition according to surgeon and perfusionist in charge.Clotting was noticed nearby blood inlet.Between the first oxygenator and the second one for replacement, there were about 15minutes gap and ecmo was applied to pt for that period.According to the values of delta p perfusionist stated that there was no record because they didn't write down in real time.(b)(4).

Manufacturer Narrative

The oxygenator was tested for its pressure drop performance.Thereby a pressure drop during maximum flow at a blood-gas-ratio 1:1 max.100 mmhg was performed.Furthermore a blood flow of 7 1/min was sustained for 10 more minutes.During this time the pressure ratio was constantly.Oxygenator passed successfully the pressure testing.Therefore the reported failure could not be confirmed.For further investigation a dhr was performed by the manufacturer.Thereby oxygenator passed all production steps and was not marked as scrap.The cause of this failure was determined to not be attributed to a device related malfunction.The data is also being handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination of applicable investigation.Due to this no further action will be completed at this time.

Manufacturer Narrative

Product was received for manufacturers investigation.Oxygenator was cleaned and disinfected.A visual inspection was performed.Thereby a small number of clots was noticed.But these clots could only be removed with sodium hypochlorite.Oxygenator was forwarded for further investigation to the qa-laboratory.A device history record was performed by the manufacturer on 09/11/2015.The complained oxygenator passed all production steps and was not marked as scrap.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

Additional info received on (b)(6) 2015: "according to perfusionist in person, they do not use a device to measure act value during operation.They have their own method to check(feel) this value.But no exact numerical value with them.According to their usual method, they did figure out act was high.".

• Brand Name: HLM TUBING SET W/ SOFTLINE COATING
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; restatt ; GM
• Manufacturer Contact: michael campbell ; 2229321132
• MDR Report Key: 5007394
• MDR Text Key: 23255304
• Report Number: 8010762-2015-00896
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup,Followup
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Model Number: VKMO 70000
• Device Catalogue Number: 70106.4523
• Device Lot Number: 92161845
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/11/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/08/2015; 11/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 75 YR