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

Model Number BEQ HLS 7050 USA

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Date 05/06/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) is aware of similar complaints which have been thoroughly investigated under nc (b)(4).An investigation of oxygenators in question showed that the venous pressure sensors are probably corroded.A white crystalline substance has been found on the pins of the pressure sensor.In the course of the investigation of (b)(4) it was found that the implausible pressure sensor readings and / or alerts displayed by the cardiohelp-i were caused by priming solution (saline solution) on the pins of the pressure sensor of the heimdall flexboard.During priming it is unlikely but possible that priming solution (saline solution) enters the hls module and gets in contact with the contact pins of the pressure sensors of the heimdall flexboard.As the cardiohelp-i supplys electrical energy to the heimdall flexboard this can result in electrolysis at the pressure sensors.The electrolytic current then falsifies the signals of the pressure sensor.Most probable situation when saline solution can reach the heimdall flexboard is the de-airing process during the priming of the oxygenator.When the user opens the luer lock some saline can drop on the surface of the hls module 7.0 / 5.0 and from there it can flow inside to the heimdall flexboard will be replaced with a coating that is resistant against saline solution.Electrolysis will then not occur in case of the unlikely event of saline solution entry into the hls module.It is the plan to verify and validate new coating and to implement the new coating into production until march 2018.

Event Description

According to the customer: "during a support run, the hls set would not provide pven readings.This would cause alarms.At varying times during the ongoing support, the pven would read and then disappear." (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: 6587059
• MDR Text Key: 76030482
• Report Number: 8010762-2017-00168
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ HLS 7050 USA
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2017
• 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