MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG DESCRIPTION FROM THE CUSTOMER REPORT:; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA

Device Problems Unable to Obtain Readings (1516); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 sensors are 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 varnish applied on pcb and plugs of venous pressure sensor does not resist the etching of the saline.Based on these results (b)(4) will be closed.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.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

Description from the customer report: "disposable was not reading the venous pressure value.Customer tried putting the same disposable on another cardiohelp device and had the same issue." (b)(4).

• Brand Name: DESCRIPTION FROM THE CUSTOMER REPORT:
• 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: 5799704
• MDR Text Key: 50550581
• Report Number: 8010762-2016-00461
• 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
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701052794
• Device Lot Number: 7010997
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2016
• 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