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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NURSEL BOELENS TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS

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NURSEL BOELENS TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HLS SET
Device Problem Incorrect Measurement (1383)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2020
Event Type  malfunction  
Manufacturer Narrative
The investigation of the manufacturer is still pending.
 
Event Description
The system was implanted on friday, (b)(6) 2020, and from the start there was the problem that the internal pressure was not displayed and instead only a dashed line could be seen in the display. As a result, the deltap display was also missing. All measures to remedy the problem did not lead to success. The connector of the pressure sensor has been disconnected from the console and the disposable product. The system was shut down and restarted. The internal pressure was not displayed. The patient was at risk. The remaining pressures were zeroed several times to the atmosphere, and did not appear to be valid. The complete system was changed on (b)(6) 2020. Since then everything has worked perfectly. A defect in the console can be ruled out. The set is no longer available; it has already been discarded complaint id: (b)(4).
 
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Brand NameTUBING SET
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
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 Key11055148
MDR Text Key223425573
Report Number8010762-2020-00448
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K102726
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,Followup,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHLS SET
Device Catalogue Number70104.7753
Device Lot Number70140720
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received02/08/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage Initial

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