MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number VKMO 50000 #

Device Problem Inaccurate Delivery (2339)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/15/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.A follow-up medwatch will be submitted when further information becomes available.

Event Description

It was reported that there were three episodes of hypoxia during the operation.Twice the oxygen saturation of the superior vena cava went from %80+ to 30+ and 50.Complaint: #(b)(4).

Event Description

Complaint: #(b)(4).

Manufacturer Narrative

It was reported that there were three episodes of hypoxia during the operation.Twice the oxygen saturation of the superior vena cava went from 80+ to 30+ and 50.No harm or death was reported.The product was not available for investigation, it was discarded by customer.Therefore laboratory investigation could not be performed.The serial number of oxygenator is not available.Therefore dhr review of oxygenator could not be reveiwed.Since affected part is not available, the exact cause could not be determined.However the reported failure could be linked to the risk assessment and control quadrox-i small adult/adult, quadrox-id adult (dms#1464420, v17) and the most probable cause could be: - oxygen concentration lower than 80%.- blockage of blood flow (clotting - anticoagulation measures - obstruction of filter).- lack of information on pressure drop /pressure increase.- lack of information on device handling (leakage of gas).The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue.Therefore, no remedial action is required.Since there are similar complaints reported, based on this the failure could be confirmed.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.H3 other text : discarded by user.

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 12243916
• MDR Text Key: 264041192
• Report Number: 8010762-2021-00419
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K090689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2022
• Device Model Number: VKMO 50000 #
• Device Catalogue Number: 70106.7966
• Device Lot Number: 92303893
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/15/2021
• Patient Sequence Number: 1