MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Lot Number 70104495

Device Problem Filtration Problem (2941)

Patient Problem Death (1802)

Event Date 07/06/2015

Event Type  Death  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device (b)(4).A supplemental medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

(b)(4).

Manufacturer Narrative

The product was not available for manufacturer's laboratory investigation as it was scrapped by the hospital.Therefore a confirmation of the failure is not possible.Three were performed in order to request the products udi (unique device identifier) for a device history record review.Additionally, further incident info was requested by our clinical application specialist.No info was provided up to date.Based on the incident information provided it was trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 5008164
• MDR Text Key: 23198039
• Report Number: 8010762-2015-00881
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K1011153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Followup
• Report Date: 10/19/2015,07/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/01/2017
• Device Lot Number: 70104495
• Date Manufacturer Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 70 YR