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

Model Number HMO 71000-J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Low Oxygen Saturation (2477)

Event Date 06/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was requested but not yet received.A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: the customer used hmo71000 for the surgery of the replacement of descending thoracic aorta the extracorporeal circulation was started.(after 6 hours) the customer observed that the po2 was low (105).The customer increased fio2 from 50% to 80%.Po2 exceeded 300.The customer observed the po2 was low (21).The customer increased fio2 to 100% and then, po2 exceeded 100.The customer increased the gas flow to10l.P02 did not go up more than 100.The extracorporeal circulation was finished.-no adverse effects on the patient -the product will be delivered to mcp (b)(4).

Manufacturer Narrative

(b)(4).The product was visually inspected in the laboratory of the manufacturer.On the blood inlet and outlet side no clots were detected.During rinsing no clots were flushed out.The product was cleaned with sodium hypochlorite solution.No other abnormalities were detected.For further examination all four sides of the oxygenator were sawn open, and the mats were inspected for any signs of damage, marks or any other anomalies.No abnormalities were found.The number of gas mats was also counted, and there are 74 mats on the gas side and 23 mats on the side of the heat-exchanger this is within specification.There were no signs of any clotting between the mats, or anything else of note.Thus the reported failure could not be confirmed.Dhr review:affected product: basic lot 70113490 and packaging lot 70113491 (serial number (b)(4)).The avz from ggx 600 to ggx 614 (b)(4) was reviewed on (b)(6) 2017.There were no references found, which are indicating a nonconformance of the product in question.Additionally a review of the weekly performance monitoring according to si-c-09 has been reviewed (b)(4), the performance tests passed the acceptance criteria.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.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

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: 6672779
• MDR Text Key: 78786235
• Report Number: 8010762-2017-00205
• 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: 09/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Model Number: HMO 71000-J
• Device Catalogue Number: 701048762
• Device Lot Number: 70113491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/12/2017
• Initial Date FDA Received: 06/28/2017
• Supplement Dates Manufacturer Received: 09/07/2017
• Supplement Dates FDA Received: 09/21/2017
• Date Device Manufactured: 11/01/2016
• 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