MAUDE Adverse Event Report: MAQUET CV ULTIMA OPCAB SYSTEM, STANDARD BLADE; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number C-OM-2001S

Device Problem Mechanical Problem (1384)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima opcab system, standard blade foot knob would not turn.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

(b)(4).A lot history record review was completed for the reported product lot number.There was no nonconformance which could be considered related to the reported event recorded in the lot history.The device was returned to the factory for evaluation.Evidence of blood and clinical use was observed.No visible defects were observed.The device was evaluated for the reported failure of the knob to turn.The knob turned freely when operated manually.An evaluation by a subject matter expert (engineering) was conducted to verify the device function.No mechanical difficulty was observed.The knob was able to turn freely with no difficulty.We were unable to reproduce the reported failure during the evaluation.

Event Description

The hospital reported that during a coronary artery bypass procedure, ultima opcab system, standard blade foot knob would not turn.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: ULTIMA OPCAB SYSTEM, STANDARD BLADE
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 5088409
• MDR Text Key: 26482595
• Report Number: 2242352-2015-01102
• 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
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 08/24/2015

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: 02/10/2017
• Device Catalogue Number: C-OM-2001S
• Device Lot Number: 25110402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2015
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR