MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-I ADULT WITH INTEGRATED FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMO 71000-J

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2015 04:24 pm (gmt-5:00) added by (b)(6) ((b)(4)): maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet (b)(4).Maquet (b)(4) requested the product back for investigation and has received it on 11/26/2015.First the product was cleaned and forwarded to the qa laboratory for testing the product regarding its performance and pressure drop performance.First the oxygenator was tested regarding its o2 and co2 transfer.Oxygenator passed successfully the performance testing.Furthermore the oxygenator was tested regarding its pressure drop performance.During maximum flow at a blood-gas-ratio 1:1 max.100 mmhg was performed.A pressure drop which was not according to our specifications could be observed during testing.As a matter of fact the integrity of the softline coating is not guaranteed after the disinfection process which involves a very aggressive solution, therefore the probability of micro clotting inside the oxygenator rapidly increases, and consequently investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

Description from the customer report: the customer felt the insufficient oxygenation of the oxygenator used for mvp & maze procedure.11:25 - extracorporeal circulation was started at fio2 60%.11:34 - arterial blood gas data: po2 - 195.8 mmhg, pco2 - 27.5 mmhg, sv02 - 86.4% 11:44 - po2 came down to 169.4 mmhg 11:48 - set fio2 to 90%.After that, the extracorporeal circulation was continued as the fio2 being controlled at 85% - 90% and po2 value being checked on the cdi monitor.Since the po2 decreased during heating, the customer controlled fio2 at 90% - 100% and then, s/he was able to keep po2 value around 300 mmhg.Normally, the customer is able to control the fio2 at 60% and the pao2 around 300mmhg when the extracorporeal circulation is started.No adverse effects on the patient.Product was not replaced.(b)(4).

Manufacturer Narrative

Feb.25, 2016 01:47 pm (gmt-5:00) added by (b)(6): for further investigation the device history record has been reviewed.The product passed every production step and was not marked as scrap.During the review no production parameters could be identified that would indicate a nonconformance during production, in regards to the reported failure.Based on these results and the information available at this time non device related factors may have contributed to the reported event.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.

Event Description

Feb.25, 2016 01:38 pm (gmt-5:00) added by (b)(6): (b)(4).

• Brand Name: QUADROX-I ADULT WITH INTEGRATED FILTER
• 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 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5287341
• MDR Text Key: 33271611
• Report Number: 8010762-2015-01228
• 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: Initial,Followup
• Report Date: 11/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2017
• Device Model Number: HMO 71000-J
• Device Catalogue Number: 70104.8762
• Device Lot Number: 70104731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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
• Patient Outcome(s): Required Intervention