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

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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.The devices displayed a similar malfunction which were tested and evaluated under an optical microscope.Delamination of some gas fibers was observed which allowed for the priming solution or blood to flow inside the gap between the gas fibers and polyurethane.Gravity then allowed for passage to the gas exiting path along the housing.The most probable root-cause is the delamination of the hollow gas fibers from the polyurethane potting area.A review of the quality control process confirms that 100% functional inspection for leakage was performed during production.Maquet cardiopulmonary (b)(4) has initiated an internal process (b)(4) to address the appropriate corrective and preventive action.A supplemental medwatch will be submitted when new info becomes available.

• Brand Name: BEQ-HMOD70000-USA#QUADROX-ID AD.O.FIL.
• Type of Device: DIFFUSIVE 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: 4365441
• MDR Text Key: 21329935
• Report Number: 8010762-2014-01348
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Remedial Action: Other
• 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: 12/16/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1