MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMO 70000-J

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The product was requested to return for manufacturers laboratory investigation but has not been received.The investigation by the manufacturer is still pending.A supplemental medwatch will be submitted when further information becomes available.

Event Description

According to the customer: "during the procedure of total arch replacement for a patient with acute type a aortic dissection, it was observed that oxygen was not being added properly.Replaced the device with another one from the same lot (from the hospital inventory) and continued the surgery." (b)(4).Also related to complaint # (b)(4) for second device replaced at the same patient.

Manufacturer Narrative

A dhr review was performed; there were no references found, which are indicating a nonconformance of the product in question.The product was investigated in the laboratory of the manufacturer.During visual inspection and during rinsing of the product no clots were detected.Several small damages were detected as follows: -cracks in the luer lock of the blood outlet connector -deformed blood inlet connector additional complaints will be opened in order to track and trend this observations.The detected cracks were sealed and the product was forwarded to the qa lab for further testing.The product was tested for its o2-transfer rate, co2-transfer rate and for pressure drop at maximum flow.The gas exchange performance test and the pressure drop test meets the specification.Thus the reported failure could not be confirmed.The cause of this failure was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in question operated within mcp specifications.

Event Description

(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: 6132060
• MDR Text Key: 61295038
• Report Number: 8010762-2016-00694
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2017
• Device Model Number: HMO 70000-J
• Device Catalogue Number: 701048759
• Device Lot Number: 70109017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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