MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-I ADULT WITHOUT FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 70104.1182

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015 12:48 pm (gmt-5:00) added by (b)(6) ((b)(4)): (b)(4).The product has not been requested for investigation by the manufacturer as the failure is already known and has been previously investigated.Maquet cardiopulmonary is aware of similar complaints from this product and an internal process ((b)(4)) was initiated to determine the most probable root-cause and to implement the appropriate corrective action.The data is being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

According to the customer: there was a leakage at the gas outlet.A few drops of blood were lost.Product was not replaced and treatment was not delayed.There was no consequence for the patient.(b)(4).

Manufacturer Narrative

On (b)(6) 2016 09:31 am (gmt-5:00) added by (b)(6) ((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.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 polypropene (pp) microporous 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 at the receiving inspection and controls, the risk is mitigated to as ¿as low as reasonably possible¿.¿.

Event Description

(b)(4).

• Brand Name: QUADROX-I ADULT WITHOUT FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5294775
• MDR Text Key: 34014524
• Report Number: 8010762-2015-01245
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2017
• Device Model Number: 70104.1182
• Device Catalogue Number: BE-HMO 70000
• Device Lot Number: 70106744
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2015
• Date Device Manufactured: 09/01/2015
• 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