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 Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.The device has been requested but not yet received.

Event Description

According to the customer: "a patient was put on cardio help v-v support on (b)(6) and the venous pressure reading was fine for about 3 hours.It then started reading p ven disconnected.The clinicians re-seated the integrated sensor cable, but this did not fix the problem.They put the system into global override to stop the alarm.I advised them that we do not recommend using global override except for priming the system.I further advised that the problem was likely a bad pressure transducer or bad pin where the integrated sensor cable connects and if they felt the patient support was being compromised by not having this value, they should change out the hls set.They were going to discuss and make a decision but doubted that they would swap the hls set out.(b)(4).

Manufacturer Narrative

The product was investigated in the laboratory of the manufacturer.The hls module was connected to the cardiohelp device.During investigation all pressures were displayed correctly.Furthermore a visual inspection was performed and it was detected that the plugs of integrated venous pressure sensor was corroded.Thus the reported failure could be confirmed.The reported failure is known to mcp based on similar complaints.An internal process was started (nc 15-02-173) in order to investigate the root cause and implement corrective actions.In the course of the investigation of nc-15-02-173 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 (article 70104.6426).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 supplies 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.The most probable root cause is that varnish applied on pcb and plugs of venous pressure sensor does not resist the etching of the saline.Maquet cardiopulmonary will implement a new coating of the affected piece part into serial production approx by january 2018.

Event Description

(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: 7079707
• MDR Text Key: 94789653
• Report Number: 8010762-2017-00379
• 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,Followup
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2018
• 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