MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLM TUBING SET W/BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HQV 34708-1

Device Problems Material Discolored (1170); Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2016 09:15 am (gmt-5:00) added by(b)(6) ((b)(4)): (b)(4).Blood leakage from the gas outlet is a known failure mode for quadrox-i adult without filter oxygenator and is identified in the risk assessment.Capa was implemented.This failure mode, also known as fiber leakage, is due to fiber breakage and results in blood leaks from the blood side to the gas side where, due to gravity, blood collects at the lowest point of the oxygenator either at the gas outlet opening or holder port.The fiber breakage is caused by cold creeping of the fibers resulting in a very slight change in the length of the fiber.Cold creeping is a natural effect of the (b)(4) fibers used in these oxygenators and occurs as the product ages.Important fiber characteristics were identified by research and were agreed upon, documented and controlled by the fiber supplier.The supplier extrusion process was reviewed and no systematic errors were identified.The supplier of the microporous fibers has established in-process controls.The maquet process for tempering of complete housing was also analyzed and counter checked by an external tempering experiment.The experiment revealed no probable process or design faults in regards to broken fibers.The maquet final tightness test was verified with master samples and approved as precise enough to detect broken fibers during the maquet manufacturing process.The described defect of leaking oxygenators will continue to be tracked and trended.With the implementation of spc (statistical process control) at the receiving inspection and controls, the risk is mitigated to as ¿as low as reasonably possible¿.

Event Description

On (b)(6) 2016 09:02 am (gmt-5:00) added by (b)(6) ((b)(4)): it was reported the oxygenator gas outlet was leaking pink fluid during perfusion.No consequence for the patient.Product was not replaced.(b)(4).

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5464550
• MDR Text Key: 39480714
• Report Number: 8010762-2016-00118
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Model Number: BE-HQV 34708-1
• Device Catalogue Number: 70106.4517
• Device Lot Number: 92170409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Date Device Manufactured: 07/02/2015
• 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