MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH BLOOD MONITORING UNIT (BMU) 40; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Catalog Number 701012218

Device Problem Gas/Air Leak (2946)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

On priming the circuit (h3000) air bubbles were noted in the bmu cell at the sensor point on the arterial line.(b)(4).

Manufacturer Narrative

The product was requested for the sample investigation.During the optical examination of the bmu sensor 2 hairline cracks were detected in the area of the sensor.To check the tightness of the bmu sensor, it was filled with air and immersed in a water bath.It.In this test, small air bubbles leaked from the sensor.The bmu sensor is leaking.Based on this, the failure could be confirmed.Getinge cp antalya has evaluated the production steps of this set.The most probable root cause was found as operator failure during production.Device history records were reviewed.No abnormality was found.Trend search was performed.No additional complaint were recorded within the last 12 months.Calculated occurrence rate: (b)(4).Which is below accepted rate- due to this information no systemic issue could be determined.The reported failure did not contribute to a death or serious injury.In addition at this time it cannot be concluded that this is a systemic error.As a corrective action operators are trained about visual controls and informed regarding complaint.No further actions needed.The data is being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

Complaint: #(b)(4).

• Brand Name: BLOOD MONITORING UNIT (BMU) 40
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8770983
• MDR Text Key: 150569753
• Report Number: 8010762-2019-00204
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• PMA/PMN Number: K090147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 12/25/2019

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 Catalogue Number: 701012218
• Device Lot Number: 70124957
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/11/2019
• Initial Date FDA Received: 07/09/2019
• Supplement Dates Manufacturer Received: 12/25/2019
• Supplement Dates FDA Received: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1