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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050 USA
Device Problem Occlusion Within Device (1423)
Patient Problem Thrombus (2101)
Event Date 04/27/2016
Event Type  malfunction  
Manufacturer Narrative
Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4). Maquet (b)(4) requested the product back for investigation but it has not been received. Investigation is still pending. A supplemental medwatch will be submitted as soon as further information becomes available. Additional information: the product mentioned under section d is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k101153.
 
Event Description
Description from the customer report: day 7 vv-ecls support. Customer noted sudden increase of delta pressure from 16 to >200mmhg. 4l/min flow @ 3500 rpm. Gas exchange adequate. Act-171 sec. Customer concerned with sudden thrombus development within membrane. No visible clot noted. The circuit was exchanged for a new primed circuit due to increase of delta p. There was no consequence to the patient. (b)(4).
 
Manufacturer Narrative
The product was tested with bovine blood for its o2 & co2 transfer rates as well of it pressure drop behaviour at maximum flow. The product was operating within the acceptance criterias and therefore passed the test. No abnormalities were detected, the product operated according to its specifications. Thus the reported failure could not be confirmed. The most probable cause of the reported failure is unknown. Based on these results and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications. Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.
 
Event Description
(b)(4).
 
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Brand NameHLM TUBING SET W/BIOLINE COATING
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 Key5644148
MDR Text Key45484715
Report Number8010762-2016-00329
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 03/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/10/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2018
Device Model NumberBEQ-HLS 7050 USA
Device Catalogue Number70105.2794
Device Lot Number70110231
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/01/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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