MAUDE Adverse Event Report: MAQUET CV STANDARD BLADES; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Catalog Number C-SB-1000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, standard blade is attached to ua 5001 ultima activator and will not come undone.The hospital did not report any patient effects.

Manufacturer Narrative

Please disregard previous entry: (b)(4).The device was returned to the factory for evaluation.Signs of clinical usage and evidence of blood were observed.Specs of blood were observed on the blades.The right blade was returned attached to the ultima drive.The platform release latch on the right side blade was broken off.There were no non-conformities observed on the left blade.No other visual defects were observed.Based on the returned condition the reported failure ¿mechanical issue¿ was confirmed.Certificate of conformance (c of c) was reviewed.The vendors certify that all the device lots manufactured conforms to all the applicable product specifications.There were no non-conformities observed.

Event Description

The hospital reported that during preparation for a coronary artery bypass procedure, standard blade is attached to ua 5001 ultima activator and will not come undone.The hospital did not report any patient effects.

• Brand Name: STANDARD BLADES
• 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: 6520834
• MDR Text Key: 73902739
• Report Number: 2242352-2017-00413
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/25/2017

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: 04/06/2018
• Device Catalogue Number: C-SB-1000
• Device Lot Number: 25124155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1