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

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) requested additional information but no further information could be provided.The customer was not able to provide any information regarding the complained products.Maquet cardiopulmonary (b)(4) is not able to review similar complaints because the identity of the product is unknown and no further information could be provided.Based on this a confirmation of the failure is not possible.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 is necessary.Due to this no further investigation initiations will be completed at this time.

Event Description

Factory received a report from the (b)(6) authority that during a symposium in (b)(6) 2015 an us colleague was reporting an event which occurred in (b)(6) were a phenomenon similar to a pressure rise occurred with an quadrox-d.The phenomenon seems to be not directly related to the product.The date of event and the identity of the products is unknown.(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5332558
• MDR Text Key: 35067368
• Report Number: 8010762-2015-01291
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1