MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG REF.: # 703005384 CUSTOMER REF.: 15-0536; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMO 71000-J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Death (1802)

Event Date 08/17/2015

Event Type  Death  

Manufacturer Narrative

(b)(6) 2015 12:04 pm (gmt-4:00) added by (b)(6): (b)(4).Maquet cardiopulmonary ag requested the product back for investigation.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

During extracorporeal circulation in thoracic aorta aneurysm case, p2 turned to 350mmhg when gradually decreasing body temperature.Me doubted quadrox-i.Clogging.Me was on blood transmission via axilla with act 600, there is no problem to oxygenation.Me changed quadrox-i to new one because flow rate was not available due to p2 increase.The product was replaced 1 hour 45 minutes after initiation of the treatment.P2 was still increased, however, me turned off the pump.Operation was over, the patient use pcps(emersave, product of terumo corporation).Flow rate was under 1l even use pcps.Me changed oxygenator same as quadrox-i, flow rate was not available neither.Duration of the treatment in total was 4 hours.Patient expired.(b)(4).

Manufacturer Narrative

(b)(4).Oxygenator was received for investigation by the manufacturer.Product was only packed in bags within a carton.No biokit was used.The oxygenator was firstly cleaned and disinfected.By performing a visual inspection, clotting in the oxygenator was noticed.During tightness test a crack on de-airing stop cock connector on upper blood outlet side was noticed.An additional complaint was opened by the manufacturer for tracking and trending the failure.For performing further investigation steps, the crack on de-airing stop-cock connector was repaired with uv glue.Without gluing the product, a pressure drop performance test would not be possible.Oxygenator was tested for its pressure drop performance.Thereby a pressure drop during maximum flow at a blood-gas-ratio 1:1 max.100 mmhg was performed.Oxygenator passed successfully the pressure testing.Therefore the reported failure could not be confirmed.The cause of this failure was determined to not be attributed to a device related malfunction.Furthermore a device history record was performed by the manufacturer.The product passed every production step and was not marked as scrap.There were no references found, which are indicating a nonconformance of the product in question.The data is also being handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination of applicable investigation.Due to this no further action will be completed at this time.

Event Description

(b)(4).

• Brand Name: REF.: # 703005384 CUSTOMER REF.: 15-0536
• 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: 5091486
• MDR Text Key: 26337264
• Report Number: 8010762-2015-01054
• 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: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 08/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Model Number: HMO 71000-J
• Device Catalogue Number: 70104.8762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention