• 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#Q
Device Problems Complete Blockage (1094); Pressure Problem (3012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/17/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. (b)(4). The device has been requested but not received.
 
Event Description
It was reported that 3 pediatric quadrox's clotted off. One oxygenator with a unknown lot # and the other two oxygenators with lot # 70115851. The two oxygenators will be handled under a separate complaint (b)(4). This report is for the oxygenator with the unknown lot#. According to the territory manager there seems to be clot in oxygenator hmod 30000 due to increase of pressure drop across oxygenator. But no clots were seen by the customer. The oxygenator was exchanged during the procedure with another one. No harm to the patient was reported. (b)(4).
 
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted when additional information becomes available. Reference exemption # (b)(4). Importer- (b)(4) requested the product for investigation in the laboratory. The product was returned but was not investigated in the complaints lab because the device may contain biological residue of who risk group 3 considered to be infectious such as hiv, hepatitis a or b. Therefore no laboratory investigation could be performed by the manufacturer. A review for similar complaints to be investigated already was performed and no similar complaints were found. Thus the reported failure could not be confirmed. To perform a dhr review is not possible at this time as no serial number is available. Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction. Since the reported failure did not contribute to a death or serious injury no corrective action is needed. In addition at this time it cannot be concluded that this is a systemic error. No corrective action is needed. The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process. Due to this no further investigation initiations will be completed at this time.
 
Event Description
Internal reference: (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 Key7560249
MDR Text Key110355649
Report Number8010762-2018-00196
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 08/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HMOD30000-USA#Q
Device Catalogue Number701050330
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 Received05/17/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-