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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 Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/26/2021
Event Type  malfunction  
Event Description
Related to (b)(4). The hospital reported that during a coronary artery bypass procedure, hst iii system (3. 8mm) did not trigger. The procedure was concluded with a new hsk.
 
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.
 
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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 Key13052115
MDR Text Key286146622
Report Number2242352-2021-01047
Device Sequence Number1
Product Code DXC
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
Report Date 12/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHST III SYSTEM (3.8MM)
Device Catalogue NumberC-HSK-3038
Device Lot Number25160733
Was Device Available for Evaluation? No
Date Manufacturer Received11/26/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/13/2021
Is the Device Single Use? Yes
Type of Device Usage Initial

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