MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD70000-USA

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 10/18/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).A supplemental medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

After initiating support on a trauma patient, while using zero anticoagulation and after nine days of use, no longer able to keep the fio2 in the 32-34 range.The best fio2 that was achievable was in the 35-36 range.Slightly lower values were desired to keep the icp low.The oxygenator was exchanged and the issue resolved.The patient was without support for two minutes while the device was changed out.A co2 transfer equation and o2 transfer equation were performed and found that the device was operating within normal parameters.The max gas flow prior to change out was 10 lpm per hospital protocol.Propofol and versed were both administered during the 9 day period.(b)(4).

Manufacturer Narrative

(b)(6).The investigation is still pending.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

An amount of 70mcg/min propofol was administered.Propofol was administered directly into subclavian central line to patient.Patient was not anticoagulated.Patient atiii level was kept at 100%.Blood flow was 4.5- 5 lpm.(b)(4).

Manufacturer Narrative

(b)(6) 2016 11:06 am (gmt-5:00) added by (b)(6) ((b)(4)): maquet (b)(4) received the product back for investigation.During visual inspection it was noted that a piece of the outer cover of the oxygenator had broken off.This was not described in the original report.For further investigation the device history record was reviewed.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.Therefore the manufacturer will not be able to confirm the failure.The data is also being handled through a designated maquet (b)(4) 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

(b)(4).

• Brand Name: QUADROX-ID ADULT DIFFUSION MEMBRANE OXYGENATOR
• 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: 5227420
• MDR Text Key: 31315288
• Report Number: 8010762-2015-01171
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: BEQ-HMOD70000-USA
• Device Catalogue Number: 70105.3824
• Device Lot Number: 701031222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/19/2015
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2015
• Date Manufacturer Received: 01/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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