• 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 AG OXYGENTOR, CARDIOPULMONARY BYPASS 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 AG OXYGENTOR, CARDIOPULMONARY BYPASS OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD30000-USA#Q
Device Problem Complete Blockage (1094)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/26/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. Reference exemption # (b)(4). (b)(4). Device was requested but not yet received.
 
Event Description
According to the customer: the perfusionist spotted a large clot in the outlet of the pediatric quadrox. More information of the territory manager received: spoke with the director of perfusion at (b)(6) hospital and he told me that he thinks the issue is with the heparin that they are receiving from their pharmacy. I think they changed suppliers and they are looking into the products efficacy. The account would like getinge to look at the oxygenator just to rule out any manufacturing issues. The customer changed out the entire circuit. No harm to the patient was reported. (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOXYGENTOR, CARDIOPULMONARY BYPASS
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY AG
rastatt
GM
Manufacturer (Section G)
BERND RAKOW
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt
GM
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
76437 rastatt 
4972229321
MDR Report Key7588005
MDR Text Key111151323
Report Number8010762-2018-00207
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K100278
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/10/2020
Device Model NumberBEQ-HMOD30000-USA#Q
Device Catalogue Number701050330
Device Lot Number70121668
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/30/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/11/2018 Patient Sequence Number: 1
-
-