MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CARDIOHELP SYSTEM; TUBING SET

Model Number BE-PLS 2051

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

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

Event Date 09/22/2014

Event Type  malfunction  

Event Description

It was reported the device was on an ecmo (extra corporeal membrane oxygenation) patient for a period of five days.During this time, a pink solution (as if condensation) was observed coming out from the bottom of the device.Pressure parameters were normal throughout treatment.The device was not swapped out.(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 is 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 information becomes available.

• Brand Name: CARDIOHELP SYSTEM
• Type of Device: TUBING SET
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4208745
• MDR Text Key: 17581245
• Report Number: 8010762-2014-00817
• Device Sequence Number: 1
• Product Code: MWJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Model Number: BE-PLS 2051
• Device Catalogue Number: 70105.0310
• Device Lot Number: 70097053
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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