MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-I SMALL ADULT/ADULT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number 01970110 #SQUADROX-I OHNE FILTEREINHEIT

Device Problem Fluid/Blood Leak (1250)

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

Event Date 08/05/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that a leakage at the gas outlet connector of the quadrox-i small adult/adult was noticed during patient treatment.The quadrox-i was exchanged during patient treatment.No harm to any person has been reported.The affected product was requested for further investigation but it was not possible to export the product out from china due to custom regulations.Thus a technical investigation could not be performed at the getinge laboratory.Therefore, no probable root cause could be determined.In addition, pictures were provided by the customer on which the reported failure "leakage at the gas outlet connector" is clearly visible.The device history review records were reviewed on 2022-08-15 for the reported failure.Following tests are performed according to the bop as a 100 % inspection: pressure test heat exchanger, leak test water/gas side, pressure test blood side, final functional test.According to the final test results, all 01970110 #squadrox-i ohne filtereinheit with packaging lot#: 3000219279 passed the tests as per specifications.Production related influences are unlikely.Based on the provided pictures by the customer the reported failure "leakage at the gas outlet connector" could be confirmed.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is 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

The event occurred in china.It was reported that a leakage at the gas outlet connector of the quadrox-i small adult/adult was noticed during patient treatment.The quadrox-i was exchanged during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).

• Brand Name: QUADROX-I SMALL ADULT/ADULT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 15257056
• MDR Text Key: 305425409
• Report Number: 8010762-2022-00329
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K150267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01970110 #SQUADROX-I OHNE FILTEREINHEIT
• Device Catalogue Number: 701067791
• Device Lot Number: 3000219279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1