• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 07/23/2018
Event Type  malfunction  
Manufacturer Narrative
Maquet cardiopulmonary is aware of a similar complaint #(b)(4) which was investigated with the following results: before opening the tub, the tensile test (checking the seal seam strength on the transport packaging) was carried out on the welded-on tyvek cover. The result was ok. During visual inspection several damages at the outer carton box were detected. Beside of this the tyvek peel cover was forced through. It was also determined that the quadrox's inlay within the tray, which is connected to the trays inner wall by welding spots, was unsoldered. Due to this the blood outlet 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. 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 (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 hls set tyvekcover has a puncture hole. No patient was involved. Complaint id: (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11222433
MDR Text Key258620215
Report Number8010762-2021-00039
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 01/25/2021
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 Date06/06/2020
Device Model NumberBEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Catalogue Number701052794
Device Lot Number70125568
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 Received07/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

-
-