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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 HLS SET
Device Problem Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/06/2024
Event Type  malfunction  
Event Description
The event occurred in usa before use.It was reported that the loading dock team identified that two out of five hls set boxes were damaged to the exterior brown box.The customer opened the brown box and two hls sets were damaged.On the provided pictures the intellipack was totally cracked/damaged and holes on the tyvek were visible.The forwarder/carrier was fedex.No harm to any person has been reported.Complaint id# (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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hechingen
Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key18961030
MDR Text Key338379617
Report Number8010762-2024-00156
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 03/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHLS SET
Device Catalogue Number701069078
Device Lot Number3000360298
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/07/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured12/08/2023
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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