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

Model Number HMOD 70000-USA

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"the patient¿s ptt¿s were therapeutic for the duration of the run and white fibrin threads were noted.The patient¿s po2¿s went from 140 to 77.At that point, perfusion was called in to do a pre and post gas of the oxygenator.The po2 going in was 30 and out was 203.Patient was not acidotic, was awake, and warm.Vent settings, i¿m assuming were at minimal settings.At that point, it was decided that the oxygenator was potential losing its function and should be changed out.A gas was taken from the new oxygenator after about 30 min and the po2¿s were in the 400¿s.The vent was turned back to min settings once ecmo was reinitiated but the patient was most likely still sedated at this point.Unfortunately, i do not know what the po2 was going in at that point.Fio2 was set to 100% the entire time, flows were never adjusted, hgb was 8".(b)(4).

Manufacturer Narrative

On (b)(6) 2017 12:00 pm (gmt-4:00) added by (b)(4): the product was discarded by the hospital and was unavailable for return; therefore, a full investigation could not be performed.The therapy application manager was requested to provide a clinical assessment for this case.Due to limited information supplied by the customer this evaluation could not be done.Therefore, a root cause cannot be determined.A dhr review was performed.283 units have been manufactured from packaging lot 70113607 from 2016-09-01 to 2016-09-10.There were no references found, which indicate a non-conformance of the product in question.No systemic issue was identified from the complaint database review but the data, however, will continue to be monitored and 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 or action is warranted at this time and the complaint will be closed.Please note this is the final report.

Event Description

Ref.: tw id # (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: 6236886
• MDR Text Key: 64733525
• Report Number: 8010762-2017-00007
• 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
• Report Date: 08/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2018
• Device Model Number: HMOD 70000-USA
• Device Catalogue Number: 701053815
• Device Lot Number: 70113607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Date Device Manufactured: 09/01/2016
• 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