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

Model Number BE-HLS 7050

Device Problem Improper Device Output (2953)

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

Event Date 12/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "pven (venous pressure) on the cardiohelp was shown no value.Product has been exchanged." (b)(4).

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).An investigation of oxygenators in question showed that the venous pressure sensor is probably corroded.A white crystalline substance has been found on the pins of the pressure sensor.The priming solution leads to an electrolysis when cardiohelp starts to work.The electrolysis starts instantly and causes a "short circuit" between the pins.The "short circuit" furthermore leads to implausible sensor pressure readings.It could be shown by a dried electrolyte plug that this state has obvious no impact on pressure sensor readings.It is obvious that the electrolyte (saline - priming solution) etches the pins of the plug.The most probable root cause is that the venous pressure sensor was exposed to fluid which leads to erroneous venous pressure readings.Mcp initiated a internal process ((b)(4)) in order to decide about further action steps.The nc is currently in the verification phase waiting for the finalized hhe (health hazard evaluation).Afterwards a decision about further action steps will be made.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation initiations will be completed at this time.

Event Description

(b)(4).

Manufacturer Narrative

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

(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: 6198288
• MDR Text Key: 63483866
• Report Number: 8010762-2016-00732
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 701047753
• Device Lot Number: 70113754
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2017
• Date Device Manufactured: 09/01/2016
• 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