MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD30000-USA

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Based on the received information a investigation of the product is not possible as the product is not available for investigation.A review for similar complaints for the specific product has been performed and no similar incident with a failure confirmed was found.Based on this a confirmation of the failure is not possible.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further investigation initiations will be completed at this time.If further information becomes available a supplemental medwatch will be submitted.

Event Description

Description from the customer report: the user reported clotting on the arterial face of the hmod30000.There were no changes to anticoagulation management.No lipids were administered.Required a change out of the product to another oxygenator.No affect to the patient was reported.Congenital diaphragmatic hernia.Oxygenator was changed in favor of another.This was veno-arterial support (b)(4).

Manufacturer Narrative

The product was disposed by the hospital; therefore no manufacturer laboratory investigation was possible.Clotting is a known phenomenon and has been investigated in a previous complaint.The cause of this failure was determined to not be attributed to a device related malfunction.Based on the results of the previous complaint investigation and the information available at this time, the oxygenator in question operated within maquet cardiopulmonary specifications.Based on the event information provided at this time the most probable cause of the reported failure could be associated with the use of the arterial luer lock connector.If hereby in each case a not adequate de-aired or low circulated flush line of a multiple way stopcock was used, or if a recirculation of the ultra filtrated blood into the system by this connector was performed could not be determined anymore.A product related malfunction is based on the provided information very unlikely.Most probable a systematic problem was causing the reported event.As the product was scrapped by the hospital the serial-number is not available, and therefore a dhr review for the specific oxygenator could not be carried out.Based on this a confirmation of the failure is not possible.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

(b)(4).

• Brand Name: QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE
• 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: 5794061
• MDR Text Key: 50408577
• Report Number: 8010762-2016-00453
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: BEQ-HMOD30000-USA
• Device Catalogue Number: 70105.0330
• Device Lot Number: 70101575
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 10/21/2016
• Date Device Manufactured: 10/01/2014
• 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
• Patient Age: 1 MO