MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ULTIMA OPCAB SYSTEM; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number ULTIMA OPCAB SYSTEM

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2020

Event Type  malfunction  

Manufacturer Narrative

Trackwise id # (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 a coronary artery bypass procedure, ultima opcab system stabilizer would not tighten.When they turned the tightener it would just endlessly spin and not tighten.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: d4: updated to reflect udi#, g4, g7, h2, h3, h6, h10.Trackwise # (b)(4).

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima opcab system stabilizer would not tighten.When they turned the tightener it would just endlessly spin and not tighten.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: ULTIMA OPCAB SYSTEM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 10121291
• MDR Text Key: 194126427
• Report Number: 2242352-2020-00479
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/02/2020

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 Expiration Date: 11/04/2021
• Device Model Number: ULTIMA OPCAB SYSTEM
• Device Catalogue Number: OM-2001S
• Device Lot Number: 25148822
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 07/29/2020
• Supplement Dates FDA Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Weight: 85