MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VENOUS HARDSHELL CARDIOTOMY RESERVOIR; FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE

Model Number VKMO 10000

Device Problem Partial Blockage (1065)

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

Event Date 08/31/2016

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device (b)(4).A follow-up medwatch will be submitted if additional information becomes available.The device has not been returned for evaluation.Additional information: the product mentioned under section is a tubing set with reservoir and the included affected component has the contributing design function of the reservoir which is registered under 510(k): k102919.

Event Description

According to the customer: "there was clotting in the reservoir during patient use." no known consequences to the patient.(b)(4).

Manufacturer Narrative

The device has not been returned for evaluation.The reservoir shows clotting according to the picture sent along with the complaint.Clotting could be confirmed.Clotting is a known phenomenon to maquet cardiopulmonary and has been thoroughly investigated in a previous complaint.The cause of this failure was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time no further investigation will be performed.This data will also be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

(b)(4).

• Brand Name: VENOUS HARDSHELL CARDIOTOMY RESERVOIR
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5946466
• MDR Text Key: 55006431
• Report Number: 8010762-2016-00561
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K102919
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2017
• Device Model Number: VKMO 10000
• Device Catalogue Number: 70105.0109
• Device Lot Number: 92178706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1