• 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 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 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD30000-USA
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/14/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has been requested but not yet received. A follow-up medwatch will be submitted when additional information becomes available.
 
Event Description
According to the customer: upon unpacking the quadrox the customer noticed the blood outlet connector was broken off. The packaging was not damaged. (b)(4).
 
Manufacturer Narrative
A beq-hmod30000-usa#quadrox-id pediatric oxygenator without filter was returned to the factory and an investigation was carried out in the decontamination / complaints laboratory. The product was inspected visually and it was found that the blood outlet connector was broken, consistent with the connector being subject to physical force or being damaged during transit. This is not a failure of the glue joint securing the blood outlet connector. Although an initial report was submitted for this issue, the investigation concludes that the issue does not constitute a reportable event, as the issue was detected upon opening the packaging, and therefore the product was excluded from any possible use on a patient. Note that as a result, no conclusion code has been entered, as no code was applicable for the reported issue.
 
Event Description
(b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOXYGENATOR, 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 Key6368475
MDR Text Key69018930
Report Number8010762-2017-00066
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
Report Date 06/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/01/2018
Device Model NumberBEQ-HMOD30000-USA
Device Catalogue Number701050330
Device Lot Number70114600
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 Received02/15/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-