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

Catalog Number C-VH-4030

Device Problems Device Inoperable (1663); Connection Problem (2900)

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

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

On 03/21/2016 11:25 am (gmt-4:00) added by (b)(6): the device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.(b)(4).

Event Description

On 02/24/2016 04:08 pm (gmt-5:00) added by (b)(6): complaint 1 of 3.See related (b)(4).On 02/24/2016 03:44 pm (gmt-5:00) added by (b)(6): the hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable had intermittent continuity and stopped working.A replacement device was used to complete the procedure.The hospital did not report any patient effects.On 02/24/2016 11:38 am (gmt-5:00) added by (b)(6): the hp2 was not cuaterizing, the black extension cord was switched and the product began to work fine.Cs customer service: please ship one unit of vh-4030 for overnight thursday delivery to my home/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 was not provided and the specific product serial 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.No other visual non-conformance was observed.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 (batch 25120795), 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

Complaint 1 of 3.See related complaints (b)(4).The hospital reported that during an endoscopic vein harvesting procedure, hemopro2 extension cable had intermittent continuity and stopped working.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The hp2 was not cauterizing, the black extension cord was switched and the product began to work fine.Cs customer service: please ship one unit of vh-4030 for overnight thursday delivery to my home/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: 5514696
• MDR Text Key: 41180491
• Report Number: 2242352-2016-00260
• Device Sequence Number: 1
• Product Code: HQO
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-4030
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: No
• Device Age: YR
• Date Manufacturer Received: 04/21/2016
• 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