• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ULTIMA ACTIVATOR II REUSABLE DRIVE MECH; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
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
Related to tw (b)(4).Summary: the hospital reported that during preparation for a coronary artery bypass procedure, ultima activator ii reusable drive mech has pitting corrosion / pitting after 4 weeks of preparation.Mechanical cleaning is carried out with the product thermosept xtra 0.5% from (b)(4).No implantation or use on the patient, but pitting / rust after processing in the washer-disinfector.
 
Event Description
Related to (b)(4).
 
Manufacturer Narrative
Trackwise (b)(4).Updated section: g4, g7, h2, h3, h6, h10.Analysis of production: (3331/213/67) the device history records review concluded that 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 manufacturing process and the reported failure mode.Historical data analysis: (4109/213/67) there were 02 additional similar complaint(s) reported for the reported failure mode and the reported serial number.A review of the product complaint trend data was performed for the months of jun 2021¿ through ¿sept 2021.The review does not identify an increasing trend or an adverse trend for three consecutive months for the product family and the failure mode.Trend analysis: (4110/213/67) the overall 24 month product complaint trend data for the period oct 2019 through sept 2021 was reviewed.There were no triggers identified for the review period.Communication/interviews: (4111/213/67) communication/interviews were performed to obtain all possible information.Testing of actual/suspected device : (10 &13 & 22) the device was returned to the factory for evaluation on 11/15/2021.An investigation was conducted on 11/23/2021.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.Evidence of corrosion was observed on the engraved numbers on the device.No other visual defects were observed.Based on the returned condition of the device, the reported failure "corroded" was confirmed.The dhr, shop floor paperwork was reviewed.The vendor certifies that this device serial/lot conforms to all applicable product specifications.
 
Event Description
N/a.
 
Manufacturer Narrative
The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.Corrected section: h-3 device not eval provide code: from "other" to "device evaluation anticipated, but not yet begun." trackwise id # (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
Manufacturer (Section G)
MAQUET CARDIOVASCULAR LLC
45 barbour pond drive
wayne NJ
Manufacturer Contact
arelean guzman
45 barbour pond drive
wayne, NJ 
MDR Report Key12606233
MDR Text Key278628402
Report Number2242352-2021-00828
Device Sequence Number1
Product Code DWS
UDI-Device Identifier00607567700901
UDI-Public00607567700901
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 12/22/2021
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 NumberC-UA-5001
Device Lot Number25153700
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2021
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 09/16/2021
Initial Date FDA Received10/11/2021
Supplement Dates Manufacturer Received11/15/2021
12/23/2021
Supplement Dates FDA Received11/22/2021
12/23/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/18/2020
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-