• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BE-HLS-7050
Device Problem Noise, Audible (3273)
Patient Problems Hemolysis (1886); Ischemia (1942)
Event Date 08/18/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation of the manufacturer is ongoing.
 
Event Description
It was reported that during patient treatment massive hemolysis, accompanied by vibration and high frequency noise originating in the device occurred. Stabilization after system and extracorporeal circuit change. No other information was provided at this time. Complaint id: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHLS SET ADVANCED
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
neue rottenburger strasse 37
hechingen
Manufacturer Contact
neue rottenburger strasse 37
hechingen 
MDR Report Key12369189
MDR Text Key268195267
Report Number8010762-2021-00474
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodePO
PMA/PMN Number
K102726
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/20/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/01/2022
Device Model NumberBE-HLS-7050
Device Catalogue Number701069073
Device Lot Number3000165548
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/19/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

-
-