MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR WITH INTEGRATED HEAT EXCHANGER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMO 71000 #SQUADROX-I ADULT + FILTER

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/19/2019

Event Type  malfunction  

Event Description

It was reported that during the emergency operation of acute aortic dissection, oxygenation of the artificial lung was observed during rewarming in the cardiopulmonary bypass (25 ° c, 32 ° c).Until then, there was no act problem and no increase in the internal pressure of the heart-lung machine.There is no problem even if the gas is flowing from the gas blowing line.Even with 100% fio2 and flow up (increase to 6.0l), oxygenation, pco2 improvement was not recognized, ivos was also reduced, oxygenation was poor even in blood gas collection.The dr.Decided to replace the artificial lung.Replaced with a new oxygenator (hmo71000) using the oxygenator bypass line.The air was removed carefully and changed.Meanwhile, the heart-lung machine was replaced without stopping.Thereafter, the improvement of oxygenation was recognized, and the operation itself was completed without any problems.Further information was requested but not yet received.Internal ref.# (b)(4), onesupport: (b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh requested the affected product for return on 2019-11-28.Sample received on 2020-01-09.The returned product was investigated in the laboratory of the manufacturer on 2020-01-30.The visual inspection of the oxygenator did not reveal any visible defects.During the leak test according to lv 201 (blood side) and the function test with the help of a roller pump, a leak was found at the de-airing port on the blood inlet side.Water drips from the de-airing port.No pressure abnormalities could be detected.Thus the reported failure could not be confirmed.The most probable root cause could not be determined.When the event occurred, the device was being used for treatment of the patient.The product was directly involved in the incident.The occurrence rate regarding the above complaint 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

Internal ref.# (b)(4), onesupport: (b)(4).

• Brand Name: OXYGENATOR WITH INTEGRATED HEAT EXCHANGER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9392257
• MDR Text Key: 200817719
• Report Number: 8010762-2019-00380
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2020
• Device Model Number: HMO 71000 #SQUADROX-I ADULT + FILTER
• Device Catalogue Number: 701067821
• Device Lot Number: 70126889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Date Manufacturer Received: 01/30/2020
• Patient Sequence Number: 1