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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG HLM TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050 USA
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Death (1802)
Event Date 03/23/2016
Event Type  Death  
Manufacturer Narrative
(b)(4). Maquet cardiopulmonary (b)(4) requested the product back for investigation but has not yet received the device. A supplemental medwatch will be submitted as soon as further information becomes available.
 
Event Description
(b)(4). Description from the customer report: customer stated that there is air in the circuit as well all in the vascular system. Customer had no idea what happened and is looking for answers. Customer has to do autopsy as they are discontinued support. Patient was on circuit as well avalon for 8 days before air was noticed. (b)(4).
 
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Brand NameHLM TUBING SET
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 Key5538702
MDR Text Key41572692
Report Number8010762-2016-00230
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
Report Date 03/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBEQ-HLS 7050 USA
Device Catalogue Number701052794
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 Date03/23/2016
Event Location Hospital
Date Manufacturer Received03/23/2016
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: 03/31/2016 Patient Sequence Number: 1
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