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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY GMBH TUBING SET 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 04/25/2018
Event Type  malfunction  
Manufacturer Narrative
Maquet gmbh requested the product for investigation in the laboratory of the manufacturer. 2018-06-13: the product was investigated in the laboratory of the manufacturer with the following outcome: when delivered, still original packed, beq-hls 7050 usa # hls set advanced 7. 0 was carried out on the outer packaging and on the inner packaging, a visual inspection was performed. The results of the investigation were documented in writing and figuratively. During the visual inspection of the returned set, various transport damages (holes, dents) were found on the outer packaging. The inner packaging (tray) has no damage except the hole in the tyvekcover. After opening the tyvekcover, it became apparent that the welded inlet to the tray had come off. The oxygenator fixed in the insert can thus move upwards towards the tyvekcover and has pushed a hole in the tyvekcover with the catch on the blood inlet connector and thus interrupted the sterility of the set. Due to this the blood connector of the unsecured product within the tray was able to force through the tyvek peel cover. This was most probable caused due to excessive physical force during transport. Thus the reported failure could be confirmed. A trend review was performed. 20 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 ((b)(6) 2018) 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
It was reported that the tyvekcover was damaged as the customer opened the outer box. Complaint id: (b)(4).
 
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Brand NameTUBING SET
Type of DeviceOXYGENATOR, 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 Key11222490
MDR Text Key231583274
Report Number8010762-2021-00045
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
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/27/2020
Device Model NumberBEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Catalogue Number701052794
Device Lot Number70123206
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/28/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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