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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-HLS 7050 #HLS SET ADVANCED 7.0
Device Problem Coagulation in Device or Device Ingredient (1096)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2020
Event Type  malfunction  
Manufacturer Narrative
A follow up medwatch will be submitted when additional information becomes available.
 
Event Description
Adult male patient under vv ecmo for 4 days using hls set with cardiohelp system. On the day 4 revealed post membrane oxygenator generate progressive thrombosis with acceptable gas exchange function as attached picture. Transmembrane pressure gradient is in the normal range ( less than 60 mmhg. ) no blood component transfusion. Blood test and coagulation function test result appt 1. 9 time, act 220 s, anti xa revealed normal. No sign of hit or anti thrombin iii deficiency. Customer decided to change to new membrane oxygenator. No consequence adverse effect to the patient. But customer would like to analyze the cause of progressive clot on post membrane oxygenator. Due to after change out the membrane was rinse of and observed; there is no clot on premembrane and centrifugal pump size. But clot was observed on post membrane oxygenator. Complaint id: (b)(4).
 
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Brand NameHLM TUBING SET W/BIOLINE COATING
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
NURSEL BOELENS
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
GM 76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
4972229321
MDR Report Key9660927
MDR Text Key204614906
Report Number8010762-2020-00045
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/25/2021
Device Model NumberBE-HLS 7050 #HLS SET ADVANCED 7.0
Device Catalogue Number70104.7753
Device Lot Number70134741
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/26/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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