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

Model Number BEQ HLS 7050 USA

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not requested to return for laboratory investigation as the failure is already known to the manufacturer and has been thoroughly investigated under (b)(4).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 comes 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.Thus the reported failure could be confirmed.In order to prevent reoccurrence of the reported issue the coating of the pins of the pressure sensor of 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 the new coating and to implement the new coating into production until march 2018.

Event Description

According to the customer: "- pven (and all pressures) correctly zeroed, then the disposable was primed.While on support of the patient, pven stopped functioning and displayed the alarm in pictures sent (above).Proper connection of the integrated sensor cable was confirmed on both the console and disposable.It was noticed the white sensor connection on the hls disposable was loose.No patient problems associated." (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: 6816884
• MDR Text Key: 83870057
• Report Number: 8010762-2017-00273
• 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: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2019
• Device Model Number: BEQ HLS 7050 USA
• Device Catalogue Number: 701052794
• Device Lot Number: 70117373
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2017
• Date Device Manufactured: 03/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1