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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 06/21/2017
Event Type  malfunction  
Manufacturer Narrative
The product was not requested to return for manufacturers laboratory investigation as the failure is known already and was investigated in a previous complaint.The outcome of the previous complaint investigation was as follows: during laboratory investigation it was confirmed that the tyvek cover was forced through.Based on the previous investigation results and the received picture a confirmation of the failure was possible.The most probable cause of the failures found is excessive physical force during transport.Furthermore a dhr review was conducted for the lot in question.There was no rework or scrap record performed during production activities a trend review was performed.16 similar complaints were found.Due to this no systemic issue could be determined.The product was not used for patient treatment.The event has been reported with a delay due to our retrospective examination of the record.At the time (2017-06-22) the complaint was reviewed and found not to be reportable.Current day, we compared the record with equivalent events, and found an inconsistency with the reporting decisions.With the current knowledge and the current team of complaint handlers, we have come to conclude the event should have been reported.As a remedial effort, we will report it within capa # (b)(4).
 
Event Description
The hls set arrived at uab and was damaged.The inner, sterile barrier was punctured.Complaint # (b)(4).
 
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Brand Name
HLS SET ADVANCED
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
neue rottenburger strasse 37
hechingen
Manufacturer (Section G)
NURSEL BOELENS
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
GM   76437
Manufacturer Contact
maquet cardiopulmonary ag
kehler strasse 31
rastatt 76437
4972229321
MDR Report Key11236302
MDR Text Key230761398
Report Number8010762-2021-00063
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date02/23/2019
Device Model NumberBEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Catalogue Number70105.2794
Device Lot Number70116942
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2017
Initial Date FDA Received01/27/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/24/2017
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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