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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ULTIMA ACTIVATOR II REUSABLE DRIVE MECH; INSTRUMENTS, SURGICAL, CARDIOVASCULAR
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MAQUET CARDIOVASCULAR LLC ULTIMA ACTIVATOR II REUSABLE DRIVE MECH; INSTRUMENTS, SURGICAL, CARDIOVASCULAR Back to Search Results
Model Number ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
Device Problem Corroded (1131)
Patient Problem No Patient Involvement (2645)
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 preparation for a coronary artery bypass procedure using ultima activator ii reusable drive mech, the products show clearly recognizable, initial rust formation after they have been processed for the first time.Products were not put into circulation, so products were not used.No patient involvement.
 
Manufacturer Narrative
Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id #: (b)(4).
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure using ultima activator ii reusable drive mech, the products show clearly recognizable, initial rust formation after they have been processed for the first time.Products were not put into circulation, so products were not used.No patient involvement.
 
Manufacturer Narrative
Trackwise # (b)(4).The device was returned to the factory on 10nov2020.An investigation was conducted on 28dec2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There is evidence of corrosion observed on the device itself.Brown spots can be observed inner edge of the drive mechanism which appears to be rust or corrosion.No other visual defects were observed.Based on the returned condition of the device, the reported failure "corrosion" was confirmed.The dhr shop floor paperwork was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The dhr shop floor paperwork is available for review as an attachment to the record.The lot # 25152118 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.
 
Event Description
The hospital reported that during preparation for a coronary artery bypass procedure using ultima activator ii reusable drive mech, the products show clearly recognizable, initial rust formation after they have been processed for the first time.Products were not put into circulation, so products were not used.No patient involvement.
 
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Brand Name
ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
Type of Device
INSTRUMENTS, SURGICAL, CARDIOVASCULAR
Manufacturer (Section D)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ 07470
MDR Report Key10755070
MDR Text Key213679821
Report Number2242352-2020-00930
Device Sequence Number1
Product Code DWS
UDI-Device Identifier00607567700901
UDI-Public00607567700901
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 10/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberULTIMA ACTIVATOR II REUSABLE DRIVE MECH
Device Catalogue NumberUA-5001
Device Lot Number25152118
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/10/2020
Was the Report Sent to FDA? Yes
Initial Date Manufacturer Received 10/06/2020
Initial Date FDA Received10/29/2020
Supplement Dates Manufacturer Received11/10/2020
01/12/2021
Supplement Dates FDA Received12/04/2020
01/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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