MAUDE Adverse Event Report: MAQUET CV HEMOPRO2 EXTENSION CABLE; UNIT, CAUTERY, THERMAL, AC-POWERED

Catalog Number C-VH-4030

Device Problem Loss of Power (1475)

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

Event Date 03/21/2016

Event Type  malfunction  

Manufacturer Narrative

Please disregard previous statement.Since the device is not available to be returned to us, a technical evaluation cannot be performed.Per our standard sop's, all events are tracked and trended to determine whether or not any trends develop.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.(b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable stopped working.A replacement device was used to complete the procedure.The hospital did not report any patient effects.Hp2 cord stopped working.(complaint 3 of 3) they opened a new cord and completed the case.Please send replacement cord to my trunk stock and i will deliver.

Manufacturer Narrative

This is a reusable oem device; therefore, a lot history review was not applicable.A lot number was not provided and the specific product lot number cannot be identified from a ship history, therefore it is impossible to obtain a certificate of conformance.(b)(4).

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable stopped working.A replacement device was used to complete the procedure.The hospital did not report any patient effects.Hp2 cord stopped working.(complaint 3 of 3) they opened a new cord and completed the case.

• Brand Name: HEMOPRO2 EXTENSION CABLE
• Type of Device: UNIT, CAUTERY, THERMAL, AC-POWERED
• 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: 5591853
• MDR Text Key: 43999366
• Report Number: 2242352-2016-00375
• Device Sequence Number: 1
• Product Code: HQO
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-4030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 06/16/2016
• 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