• 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 BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing. Further information has been requested but has not yet been received. A follow up medwatch will be submitted when additional information becomes available.
 
Event Description
Customer received two hls kits that had punctures in the top of the internal pack. Outer boxes were not damaged. 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 Key12686640
MDR Text Key278090174
Report Number8010762-2021-00567
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Catalogue Number701052794
Device Lot Number3000179558
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/28/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

-
-