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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 02/17/2020
Event Type  malfunction  
Event Description
There was a coagulation of the membrane on set be-hls 7050, lot 70130424. The hospital replaced the set and threw away the coagulated set. (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 Key9773935
MDR Text Key192167146
Report Number8010762-2020-00088
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeSI
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/22/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBE-HLS 7050#HLS SET ADVANCED 7.0
Device Catalogue Number701047753
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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