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 Code Available (3191)

Event Date 11/02/2016

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).The product was requested but not yet received.The investigation of the manufacturer is still pending.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

"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.Although the customer switched the device, the po2 stayed around 170 and didn¿t go up more than that even though they increased fio2 and the flow (now they are talking about the problem on the device #2).After they stopped the circulation, the po2 went up to 190-200, so, the customer continued to use the device#2 and finished the procedure.Ref # (b)(4).Also related to complaint #(b)(4) for first 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 no clots were detected.At the luer lock connector of the blood outlet connector and at the blood outlet connector itself small cracks were detected.Additional complaints will be opened in order to track and trend this observation.The cracks were sealed for further testing purposes.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.Since the reported failure did not contribute to a death or serious injury and no systemic issue could be determined no corrective action is needed at this time.

Event Description

(b)(4).Also related to complaint # (b)(4) for first device replaced at the same patient.

• 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: 6132642
• MDR Text Key: 61407174
• Report Number: 8010762-2016-00697
• 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: 11/01/2017
• Device Model Number: HMO 70000-J
• Device Catalogue Number: 701048759
• Device Lot Number: 70109017
• Was Device Available for Evaluation?: Yes
• 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