MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC VASOVIEW HEMOPRO 2; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VASOVIEW HEMOPRO 2

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2021

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 an endoscopic vein harvesting procedure, vasoview hemopro 2 bbt port on the device would not let co2 flow.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

Updated sections: g4, g7, h2, h6, h10.Trackwise # (b)(4).The lot # 25155350 history record review was completed.There were ncmrs , rework, or deviations documented for the reported lot number.Ncmr #17217- a discrepancy in the maximum dose specification on the certificate of processing (max dose specification = 38 kgy) was identified for twelve (12) gamma process loads (b)(6) 2020) that were reviewed against the revised, released procedure 90519293 rev bk (maximum dose specification = 40 kgy).].Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, vasoview hemopro 2 bbt port on the device would not let co2 flow.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

• Brand Name: VASOVIEW HEMOPRO 2
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 11375987
• MDR Text Key: 233443056
• Report Number: 2242352-2021-00167
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00607567700406
• UDI-Public: 00607567700406
• Combination Product (y/n): N
• PMA/PMN Number: K101274
• 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: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2022
• Device Model Number: VASOVIEW HEMOPRO 2
• Device Catalogue Number: C-VH-4000
• Device Lot Number: 25155350
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1