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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 #SHLS SET ADVANCED 7.0
Device Problem Partial Blockage (1065)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2024
Event Type  malfunction  
Event Description
It was reported that the hls circuit clotted off within hours of placing the patient on support.According to the customer the patient¿s elevated hct on initiation could have been the problem.The failure occurred during treatment.No harm to any person has been reported.(b)(4).
 
Manufacturer Narrative
A follow-up medwatch will be submitted when additional information becomes available.
 
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Brand Name
TUBING SET
Type of Device
OXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
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MDR Report Key18795991
MDR Text Key336399519
Report Number8010762-2024-00108
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/28/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/28/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberBEQ-HLS 7050 USA #SHLS SET ADVANCED 7.0
Device Catalogue Number701069078
Device Lot Number3000349686
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/27/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/06/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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