MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problems Locking mechanism failure (2593); Output Problem (3005)

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

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).The manufacturer is aware of similar complaints for the failure "venous pressure not measurable".An internal process (b)(4) was initiated to determine the most probable root cause and to implement the appropriate corrective action.The data will be handled through a designated maquet trending process.If a trend develops, it will be escalated to quality assurance management for review and determination if further investigation is needed.Additional information: the product mentioned under section d 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.(b)(4).

Manufacturer Narrative

The former mentioned (b)(4) was transferred into the nonconformance process with reference #(b)(4) with the following outcome: 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 fo 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 0 priming solution ) etches the pins of the plug.The most probable root cause is that the varnish applied on pcb and plugs of venous pressure sensor does not resist the etching of the saline.Based on these results complaint # (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.

Event Description

(b)(4).

• Brand Name: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4673639
• MDR Text Key: 16631046
• Report Number: 8010762-2015-00315
• 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: Health Professional,User Facility,health professional,use
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No Information
• Date Manufacturer Received: 03/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1