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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/07/2020
Event Type  malfunction  
Manufacturer Narrative
A follow-up emdr will be submitted when additional information becomes available.
 
Event Description
The conclusion is that the centrifugal hood for whatever reason stopped working, making the flow positive and making it retrograde. It is decided to change the device to another console. It keeps presenting the same problem. Faced with the non-response of all the previous actions, the change of the membrane is decided, in the same console that the patient had on. Once the latter is done, circulatory support is restored without incident. Complaint #: (b)(4).
 
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Brand NameHLS SET ADVANCED 7.0
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 Key10696416
MDR Text Key211903681
Report Number8010762-2020-00348
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBE-HLS 7050 #SHLS SET ADVANCED 7.0
Device Catalogue Number70106.9073
Device Lot Number70141701 (HLS MODULE)
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2020
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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