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

Catalog Number C-VH-4020

Device Problem Break (1069)

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

Event Date 08/04/2016

Event Type  malfunction  

Manufacturer Narrative

(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, hemopro 2 adaptor collar was broke.Tape was used to hold it in place.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.

Manufacturer Narrative

(b)(4).This is a reusable oem device; therefore, a lot history review was not applicable.The product is not returning.A serial number was not provided for this device, therefore it is impossible to obtain a certificate of conformance.

Event Description

The hospital reported that during an endoscopic vein harvesting procedure, hemopro 2 adaptor collar was broke.Tape was used to hold it in place.A replacement device was used to complete the procedure.The hospital did not report any patient effects.The product is returning.

• Brand Name: HEMOPRO2 ADAPTOR
• 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: 5919359
• MDR Text Key: 54282775
• Report Number: 2242352-2016-00835
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-VH-4020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 10/05/2016
• 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