MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050#HLS SET

Device Problems Increase in Pressure (1491); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

Patient Problem Death (1802)

Event Date 08/14/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).(b)(6).Maquet (b)(4) requested the product for investigation in the laboratory of the manufacturer, but the hls set was discarded by the hospital and therefore it is not any longer available for investigation.Lot number is also unknown.According to the customer: "the customer didn´t feel there was an issue to report with the hls set." a clinical assessement was requested.According to the conclusion of the clinical assessement: "given the fact that dic has been verified in the patient it has been outlined above that this syndrome fits well with the clinical situation reported in the complaint.Dic can lead to both hypercoagulative states and reduced coagulation resulting in bleeding and reduced clotting at almost the same time.The increase transmembrane pressure without significantly visible clots can exactly reflect the oscillating states of coagulation that characterizes dic.With the information given no product related failure can be determined.The information about the tragic case most likely substantiate a disseminated coagulopathy leading to clotting in the oxygenator and subsequent pressure increase." thus the reported failure could not be confirmed.The data is 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.

Event Description

According to the initial complaint report: "ecmo was initiated on patient with circuit as above.Customer has complained that the oxygenator transmembrane pressure increased from 10 - 100mmhg and the flow dropped from 3l/min to 0.3l/min.Clinically this showed an oxygenator that was blocked due to blood clotting.The customer has explained that there was no obvious signs of clotting on visual inspection of the oxygenator.The used pls set will be handle in complaint# (b)(4).The customer swapped the patient onto a hls cardiohelp ecmo circuit, subsequently flow to the patient was restored.The customer did comment though that the hls circuit also began to increase pressures and drop flow.This incident occurred on the (b)(6) 2018, the patient passed away on this date in icu.The patient had a number of disease processes present at time of ecmo therapy.It was reported to me that she was a lung transplant patient who at the time of ecmotherapy had disseminated intravascular coagulopathy and lupus antibodies.The customer has reported to me that this case will be investigated and reported to the coroner." also received a potential root cause from the customer "patient condition causing oxygenator to become blocked.Internal reference: (b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, 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: 7797719
• MDR Text Key: 117610266
• Report Number: 8010762-2018-00247
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050#HLS SET
• Device Catalogue Number: 701047753
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death