MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLS SET ADVANCED 7.0; BE-HLS 7050#HLS SET ADVANCED 7.0

Model Number BE-HLS 7050

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

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

Event Date 11/25/2014

Event Type  Injury  

Event Description

It was reported that after connecting the device to a patient, blood leakage as drops were observed at the gas outlet.The device was exchanged.No reported patient effect.(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 ag has initiated an internal process (capa-(b)(4)) to address the appropriate corrective and preventive action.A supplemental medwatch will be submitted when new information becomes available.The product mentioned under section d is a tubing set and the included affected component has the contributing design function of the quadrox-id which is registered under 510(k): k101153.

• Brand Name: HLS SET ADVANCED 7.0
• Type of Device: BE-HLS 7050#HLS SET ADVANCED 7.0
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4359807
• MDR Text Key: 5118282
• Report Number: 8010762-2014-01359
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 70104-7753
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention