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

Model Number VKMO 10000

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Thrombus (2101)

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The reservoir shows clotting.According to the picture sent along with the complaint clotting could be confirmed.(b)(4).The device has not been returned for evaluation.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.Additional information: the product mentioned under section d 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): (b)(4).

Event Description

According to the customer: "there was clotting on the screen filters of the reservoir during the operation." no known consequences to the patient.(b)(4).

• Brand Name: VENOUS HARDSHELL CARDIOTOMY RESERVOIRS
• Type of Device: FILTER, BLOOD, CARDIOPULMONARY BYPASS, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5151326
• MDR Text Key: 28755192
• Report Number: 8010762-2015-01101
• 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
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2016
• Device Model Number: VKMO 10000
• Device Catalogue Number: 70105.0109
• Device Lot Number: 92156235
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2015
• Date Device Manufactured: 01/01/2015
• 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