MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-PLS 2050

Device Problems Partial Blockage (1065); Misconnection (1399); Improper Flow or Infusion (2954)

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

Event Type  malfunction  

Manufacturer Narrative

The product in question is not available for investigation; therefore manufactures laboratory investigation was not possible.Based on the incident information provided the following clinical assessment was made: the user always has to make certain during the preparation as well as during startup of the system, that all tubes will be provided with the intended connectors and furthermore the correct flow direction is addressed.The described incident represents a situation under pressure of time.As a v-a patient, who's supported with an ecls / ecmo system is generally totally dependent from the ecc system, a system change - as happened - represents a challenging situation for the whole clinical team - as well as for the patient.Expectedly, the therefor necessary reduction of the heart and lung support to the point of a full interruption of the ecc, represents a significant insufficient supply of all organs - including the brain; and also additional time is needed for disconnection, reconnection as well as for de-airing of the system.Due to this the clinicians are forced to perform a fast replacement maneuver.

Event Description

According to the customer: during cannulation from ecmo to hlm.Hlm is ready to take over this support.Pls is stopped by perfusionist 2.Surgeon puts clamps quickly on both peripheral lines and cut this.At this time, is no longer directly visible which is arterial cannula and cannula which is venous (color marker has been cut off and the rest of the line under neath the sterile or blankets).Hlm hoses are being connected to the peripheral cannulas.Perfusionist one looks for pulsations are arterial line.These are there, but have not been clearly be seen.Hlm is initiated by the perfusionist 1.However, there is no good / full-flow that can be achieved (about 2.5 lpm).There is also be a absorbed a small clot coming to sit tight in the venous collapsable reservoir which was conceived as a cause of poor drainage.Arterial blood pressure patient falls directly.Cvd is not rising.It is everyone responsibility in the or to find out what's going on.Perfusionist 2 will see quickly that the tubes of the hlm are wrong connected to the peripheral cannulas.Hlm is stopped.It is again to be re-cannulated hlm is started again,which can now be accessed directly full flow.(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• 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: 5956454
• MDR Text Key: 54944908
• Report Number: 8010762-2016-00568
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: BE-PLS 2050
• Device Catalogue Number: 70102.7818
• Device Lot Number: 70104106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2016
• Date Device Manufactured: 05/01/2015
• 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