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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM) CLAMP, VASCULAR

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MAQUET CARDIOVASCULAR LLC HST III SYSTEM (3.8MM) CLAMP, VASCULAR Back to Search Results
Model Number HST III SYSTEM (3.8MM)
Device Problem Fitting Problem (2183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2021
Event Type  malfunction  
Manufacturer Narrative
Trackwise id # (b)(4). The device has not yet been returned to maquet cardiac surgery for evaluation. We are following up with the customer for the return of the device. A supplemental report will be submitted if the device is received.
 
Event Description
The hospital reported that during a coronary artery bypass procedure, hst iii system (3. 8mm) could not be loaded. The umbrella got stuck in the loading unit, it wasn't usable like that. Hsk was not used on the patient.
 
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Brand NameHST III SYSTEM (3.8MM)
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ
Manufacturer Contact
arelean guzman
45 barbour pond drive
wayne, NJ 
MDR Report Key12780708
MDR Text Key280587092
Report Number2242352-2021-00948
Device Sequence Number1
Product Code DXC
UDI-Device Identifier00607567700314
UDI-Public00607567700314
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K130382
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Expiration Date06/03/2022
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25158642
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received01/21/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/03/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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