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

Model Number BEQ-HLS 7050 USA

Device Problem Unable to Obtain Readings (1516)

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

Event Date 04/13/2016

Event Type  malfunction  

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) requested the product back for investigation but has not received it to date.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.Additional information: the product mentioned is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k101153.

Event Description

It was reported that the venous pressure was not getting a reading.Incident occurred before use / procedure.(b)(4).

Manufacturer Narrative

The record was again reviewed and it was determined that the product was requested but not returned yet.However, it was also determined that a product investigation is not needed for this complaint as the failure is already known.Maquet cardiopulmonary (b)(4) is aware of similar complaints which have 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 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.Corrective action plan: 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: OXYGENATOR, 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: 5633758
• MDR Text Key: 45003276
• Report Number: 8010762-2016-00315
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• 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: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701052794
• Device Lot Number: 70108428
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• Date Device Manufactured: 12/01/2015
• 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