• 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 QUADROX-ID SMALL ADULT/ADULT 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 QUADROX-ID SMALL ADULT/ADULT OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD70000-USA
Device Problem Infusion or Flow Problem (2964)
Patient Problem Air Embolism (1697)
Event Date 08/05/2021
Event Type  Death  
Manufacturer Narrative
The investigation of the manufacturer is ongoing.
 
Event Description
It was reported that a patient was on vv ecls (veno venous extracorporeal life support) since (b)(6) 2021 for covid. They had received 4 oxy changeouts during the run of which, the last(this oxygenator) was done morning of the death of the patient. On the afternoon of (b)(6), the patient was clamped out due to hemodynamic instability seeming to stem from right heart failure. There was massive air found in the hepatic veins and ivc (vena cava inferior). There were no issues with the changeout and there was never any air seen in the circuit and the rotaflow bubble alarm never went off. The customer was able to flow between 5 and 6 lpm (liter per minute) consistently between the changeout and when he clamped out. Complaint id: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameQUADROX-ID SMALL ADULT/ADULT
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 Key12394552
MDR Text Key269029141
Report Number8010762-2021-00480
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K101153
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 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HMOD70000-USA
Device Catalogue Number701067859
Device Lot Number3000163294
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/31/2021 Patient Sequence Number: 1
-
-