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 Malposition of Device (2616)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Additional information was requested but not yet received.

Event Description

Facility medwatch report # (b)(4) received (b)(6) 2017.Patient on ecmo in ct-icu.Ecmo circuit negative pressure abnormally high.Dr contacted for possible cannula malposition.Ecmo tech troubleshooting circuit.Dr attempted to reposition cannula without success.Patient taken to ctor for cannulation reposition.Ecmo tech added a negative pressure port and monitored response.The additional negative pressure monitoring showed acceptable negative pressure readings.It was determined that the cardiohelp ecmo pressure source was malfunctioning.(b)(4).

Event Description

(b)(4).

Manufacturer Narrative

The reported failure is known to mcp based on similar complaints.An internal process was started ((b)(4)) in order to investigate the root cause and implement corrective actions.Since november 2013 customers reported implausible pressure sensor readings and / or alerts displayed by the cardiohelp-i.Investigations of affected hls 7.0 oxygenators showed scaling on the solder side of the heimdall flexboard, material no.: 70104.6426, at the contact pins of the venous 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 (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.Maquet cardiopulmonary was implementing a new coating of the affected piece part into serial production by january 2018.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7171850
• MDR Text Key: 96939019
• Report Number: 8010762-2018-00005
• 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
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• 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
• Date Manufacturer Received: 02/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1