MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID ADULT OXYGENATOR WITH SOFTLINE COATING WITH SCREW CONNECTOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMOD 70000-USA #SQUADROX-ID ADULT O.FILT

Device Problem Pressure Problem (3012)

Patient Problem Death (1802)

Event Date 11/14/2019

Event Type  Death  

Manufacturer Narrative

Maquet (b)(4) requested the product in question for further investigation but the disposable was already disposed.Therefore no laboratory investigation could be performed by the manufacturer.A review for similar complaints to be investigated was performed and no similar complaint was found.A medical review was performed on 2020-02-06.Results: the oxygenator device in question has been changed out due too high transmembrane pressure (delta-p).It has been further stated that the heparin supply was intermittent during the course of the extracorporeal circulation.The scale of clinical therapy with the involved medical devices, as stated above, is pointing to a very challenging anticoagulation protocol.Neither from the anamnesis known or perioperative acquired coagulation disorders are known.According to the information it is conceivable that coagulation disorders and subsequent challenges within the anticoagulation management were present and led to the increased transmembrane pressure of the device in question or could have promote.Without further information no reliable conclusions can be drawn.The corresponding patient did expire unrelated to the oxygenator that was changed according to the chief of perfusion at the site of the event.Thus the failure could not be confirmed.No root cause could be determined.The occurrence rate is below the acceptance rate, thus no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary´s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Spoke with (b)(6) ccp.He advised the ssu that during therapy with the oxygenator that was "changed out" with lot 70132529 the heparin was being started and stopped during therapy.(b)(6), the chief of perfusion at (b)(6) university hospital stated: " we just changed out oxygenator.Dr (b)(6) wants us to contact maquet and find out why there is such a gradient.Lot 70132529: 200 mmhg (changed) lot 70133375: 130 mmhg (new)." new information received on 2019-11-22 by the ssu: the patient expired unrelated to the oxygenator that was changed.Complaint id: (b)(4).

• Brand Name: QUADROX-ID ADULT OXYGENATOR WITH SOFTLINE COATING WITH SCREW CONNECTOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9694578
• MDR Text Key: 178597356
• Report Number: 3008355164-2020-00003
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2021
• Device Model Number: HMOD 70000-USA #SQUADROX-ID ADULT O.FILT
• Device Catalogue Number: 70106.7840
• Device Lot Number: 70132529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/11/2020
• Distributor Facility Aware Date: 02/07/2020
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/19/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention