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 03/23/2016

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.Another cord was opened and the case was completed without incident.(they have reported 3 cord failures, so this is 1 of 3 complaint reports.) please ship replacement vh-4030 to my trunk stock and i will deliver to customer.

Manufacturer Narrative

(b)(4).This is a reusable oem device; therefore, a lot history review was not applicable.A lot number /serial 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 the device was returned to the factory for evaluation.A visual inspection was conducted.The device showed no signs of clinical usage and no evidence of blood.The cord was broken at the jacket/collar of the 4 pin connector.The detached jacket/collar was not returned.The device was evaluated for connector function.The cable was able to provide a secure connection that connected and disconnected without incident.An electrical evaluation was performed.A pre-cautery test was performed per the instruction for use (ifu) with a reference hemopro 2 , reference adapter cable and reference power supply vh-3010 at level 3.0.The device passed the pre-cautery test; it produced steam and heat during 5-second activations and shut off when the toggle was released.A polyfuse electrical test was performed with the same reference power supply, adapter cable and hemopro 2; the polyfuse successfully shut off power to the heater after prolonged periods of time and activated after the device cooled.Based upon the evaluation results, the reported complaint was not able to be confirmed for the reported failure mode "failure to deliver energy/ intermittent energy" but was confirmed for as analyzed failure mode "break-cord".

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.Another cord was opened and the case was completed without incident.(they have reported 3 cord failures, so this is 1 of 3 complaint reports.) please ship replacement vh-4030 to my trunk stock and i will deliver to customer.

• 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: 5591848
• MDR Text Key: 43806638
• Report Number: 2242352-2016-00373
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2016
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 06/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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