MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BLOOD GAS MONITOR

Model Number BMU 40

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Event Description

According to the customer: "issues with two the arterial probe.It indicates "malfunction of the arterial temperature sensors.There are currently no valid arterial measured values available." the issues appear to occur when the sensors are exposed to blood after prime/crystalloid.They appear to not agree with the change in fluid.(b)(4).

Manufacturer Narrative

The device has been investigated by the service support of maquet cardiopulmonary ag and it was determined that the arterial board and arterial probe are defective.The arterial board and arterial probe have been exchanged by the service support of maquet cardiopulmonary ag.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

• Brand Name: BLOOD GAS MONITOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4730195
• MDR Text Key: 5702900
• Report Number: 8010762-2015-00393
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K090147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/31/2015

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 Model Number: BMU 40
• Device Catalogue Number: 70104.0852
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2015
• Initial Date FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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