MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL.; DIFFUSION MEMBRANE OXYGENATOR

Device Problems Increase in Pressure (1491); Pressure Problem (3012)

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

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary is aware of similar complaints, showing a similar malfunction.The failure investigation will be performed under complaint number (b)(4).The results of this investigation are still pending.A supplemental report will be submitted when additional info becomes available.(b)(4).

• Brand Name: BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL.
• Type of Device: DIFFUSION MEMBRANE OXYGENATOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4365456
• MDR Text Key: 17573976
• Report Number: 8010762-2014-01341
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1