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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HMOD70000-USA
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Information (3190)
Event Date 06/21/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4). A follow-up medwatch will be submitted if additional information becomes available.
 
Event Description
According to the customer: the customer shared that children's hospital of new orleans had used a adult quadrox id on a neonate with an adverse outcome. He reported complications with and he raised concerns about using the adult qid's with neonate. He expressed concerns regarding priming volumes and minimum flow rates. This report is in reference to baby number three. This is the third report to add to (b)(4).
 
Manufacturer Narrative
The clinician used the adult oxygenator for the purposes of extracorporeal oxygenation of and carbon dioxide removal from human blood for the pediatric patient due to the fact that the clinic did not have a neonate or pediatric device available. Quadrox-i adult is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. The device oxygenates the blood, eliminates carbon dioxide from the blood and regulates blood temperature. The quadrox-i adult (hmo 71000) version with integrated arterial filter also filters out air bubbles and particles larger than 40 um. The device¿s utilization period is limited to six hours. Responsibility for deciding whether to use an oxygenator rests solely with the attending physician. Several attempts were performed to obtain more information from the customer about which performance parameters he was concernd of as well about the lot # and the udi of the oxygenator in order to perform a dhr review. No information was provided up to date. The cause of this failure was determined to not be attributed to a device related malfunction. Based on these results and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.
 
Event Description
(b)(4).
 
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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 Key5805479
MDR Text Key49897915
Report Number8010762-2016-00470
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K101153
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 06/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBEQ-HMOD70000-USA
Device Catalogue Number701053824
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/21/2016
Event Location Hospital
Date Report to Manufacturer06/21/2016
Date Manufacturer Received07/21/2016
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

Patient Treatment Data
Date Received: 07/19/2016 Patient Sequence Number: 1
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