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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 Type  Injury  
Manufacturer Narrative
Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4). As per the clinical assessment and according to the ifu quadrox-id adult the device is oxygenating blood, removes carbon dioxid from the blood and regulates the blood temperature within the specified flow rate range. The products minimun blood flow starts at 0. 5 l/min. A baby / neonate usually requires an blood flow of 80 to 120 ml/min. For this application the quadrox-id pediatric with a blood flow rate of 0. 2 - 2. 8 l/min or the quadrox-i neonatal with a blood flow rate of 0. 2 to 1. 5 l/min seems to be more adequate. To use an product for neonates which is designed for adults is inadequate and it should be clear that the specifications of the quadrox id adult are inappropriate for neonates. Several attempts were peformed to obtain more information from the customer about which performance parameters he was concernced 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. Based on this the most probable cause of the reported incident is an user error. 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. A supplemental medwatch will be submitted when further information becomes available. (b)(4).
 
Event Description
The customer shared that (b)(6) hospital of (b)(6) had used two adult qids on two different neonates. He reported complications with both and he raised concerns about using the adult qid's with neonates. He expressed concerns regarding priming volumes and minimum flow rates. This report is in reference to baby number two. No specific information was shared regarding the baby.
 
Manufacturer Narrative
In the previous mdr our initial review of the information led it to an incorrect assessment that the issue identified was due to user error. After further review of the information provided, this was not the case. 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.
 
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 Key5702217
MDR Text Key46660677
Report Number8010762-2016-00367
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
Type of Report Initial,Followup
Report Date 05/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HMOD70000-USA
Device Catalogue Number70105.3824
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 Date05/18/2016
Event Location Hospital
Date Report to Manufacturer05/18/2016
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: 06/06/2016 Patient Sequence Number: 1
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