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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR

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MAQUET CV HS III PROXIMAL SEAL SYTEM 3.8MM CLAMP, VASCULAR Back to Search Results
Catalog Number C-HSK-3038
Device Problems Device Expiration Issue (1216); Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/16/2018
Event Type  malfunction  
Event Description
The hospital reported that during a coronary artery bypass procedure, hs iii proximal seal system 3. 8mm seal did not load correctly. They were advised that this product had expired on 12/02/2017. The hospital did not report any patient effects. A replacement device was used to complete the procedure.
 
Manufacturer Narrative
Internal complaint number trackwise # (b)(4). Autonumber # (b)(4). The lot history review indicated that the unit was expired at the time of use.
 
Manufacturer Narrative
(b)(4). A lot history record review was completed for the reported product lot number. There was no nonconformance recorded in the lot history. 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, hs iii proximal seal system 3. 8mm seal did not load correctly. They were advised that this product had expired on (b)(6) 2017. The hospital did not report any patient effects.
 
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Brand NameHS III PROXIMAL SEAL SYTEM 3.8MM
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
MAQUET CV
45 barbour pond drive
wayne NJ 07470
MDR Report Key7249752
MDR Text Key281971043
Report Number2242352-2018-00121
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
PMA/PMN Number
K080169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/02/2017
Device Catalogue NumberC-HSK-3038
Device Lot Number25129853
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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