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

Model Number ULTIMA ACTIVATOR II REUSABLE DRIVE MECH

Device Problem Corroded (1131)

Patient Problems No Consequences Or Impact To Patient (2199); 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drive mech.Corrosion / rust formation during processing by the cssd.Sterilization: steam 134 ° c 5min.Device was withdrawn from circulation by employees of the cssd.The hospital did not report any patient effects.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure using ultima activator ii reusable drive mech.Corrosion / rust formation during processing by the cssd.Sterilization: steam 134 ° c 5min.Device was withdrawn from circulation by employees of the cssd.The hospital did not report any patient effects.

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).

Manufacturer Narrative

Trackwise #: (b)(4).Corrected section: b5- summary, h6- corrected to "not patient involved." the device was returned to the factory on 03dec2020.An investigation was conducted on 21jan2021.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.All the letters and numbers on the drive mechanism appear to be rusted or corroded.No other visual defects were observed.Based on the returned condition of the device, the reported failure "corrosion" was confirmed.The reported device is an oem device.The certificate of conformance was reviewed for the serial #: (b)(6).The vendor certifies that this device lot conforms to all applicable product specifications and there were no non-conformances identified for the manufacturing batch.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure using ultima activator ii reusable drive mech.Corrosion / rust formation during processing by the cssd.Sterilization: steam 134 ° c 5min.Device was withdrawn from circulation by employees of the cssd.No patient involved.

• 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 Key: 10937549
• MDR Text Key: 219320620
• Report Number: 2242352-2020-01055
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 00607567700901
• UDI-Public: 00607567700901
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ULTIMA ACTIVATOR II REUSABLE DRIVE MECH
• Device Catalogue Number: UA-5001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1