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 Problem No Patient Involvement (2645)

Event Date 08/25/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.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, ultima activator ii reusable drive mech locker shows rust after the second sterilization.No patient involvement.

Manufacturer Narrative

(b)(4).The lot # 25151916 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.The device was returned to the factory on 11/04/2020.An investigation was conducted on 11/12/2020.A visual inspection was conducted.Signs of clinical use and no evidence of blood was observed.There was slight evidence of discoloration on the base of the ultima activator ii reusable drive mech.There were no other visual defects 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.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, ultima activator ii reusable drive mech locker shows rust after the second sterilization.No patient involvement.

• 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: 10556872
• MDR Text Key: 207722516
• Report Number: 2242352-2020-00795
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2020
• 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
• Device Lot Number: 25151916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1