MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Device Problem Air Leak (1008)

Patient Problem Death (1802)

Event Date 12/08/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Maquet cardiopulmonary has not received detailed product information about the cannula device in question so far.In addition the cannula was requested for investigation but has not been received yet.The product failure investigation, analysis and resolution for the device described in this report will be provided by maquet cardiopulmonary ag.A supplement medwatch will be submitted as soon as additional information becomes available.

Event Description

It was reported that according to additional information received from the customer in reference to the complaint (b)(4) that the air intake resulting into the patients death could have been caused by a central catheter (not a maquet product) placed near the tip of the venous cannula (a maquet product).No detailed product information about the cannula device in question is available so far.(b)(4).

Manufacturer Narrative

The venous cannula was received together with the hls tubing set investigated in (b)(4) (mfr report # 8010762-2015-01287).Note that this complaint relates to exactly the same adverse event (patient death) as already reported in mfr report # 8010762-2015-01.The root cause of the air entry cannot be determined with certainty because of insufficient information about the incident, the patient, and the circumstances.Note that if the venous cannula was used during application in the same state as the hls-set arrived in at maquet this would be off label use.Training was provided to the users by the sales representatives who met with the medical staff on 05-jan-2016.Based on the results of the investigation and due to insufficient information for precise determination of root cause, even after a good faith effort, there is currently no further investigation or action possible.However, 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 should prove necessary or possible.Consequently, the complaint will be closed.This supplemental report also serves as the final report.

Event Description

(b)(4).

• Brand Name: VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5347868
• MDR Text Key: 35173207
• Report Number: 8010762-2016-00006
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• 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
• Patient Outcome(s): Death