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

Model Number QUADROX-I ADULT (VKMO)

Device Problem Leak/Splash (1354)

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

Event Date 07/03/2019

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Leaking at side cover of oxygenator during priming procedure.Action: replace the oxygenator.(b)(4).

Event Description

Complaint #(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary gmbh was requested the product back for technical investigation on (b)(6) 2019.Product was sent on (b)(6) 2019 and received by manufacturer on (b)(6) 2019.The technical investigation was performed on (b)(6) 2019.There were no deficiencies found during visual investigation.Leak test was performed with water per lv 201 to the blood side and leakage was detected from the blood side to the gas side of the product.The leak test per lv 202 on water side is in order.Based on this failure could be confirmed.Device history record for complaint 225980 and lot 70121920 has been reviewed on 2019-08-05 (dms# 2595190).There are no evidences indicating a non conformance or deviations of the product in question during the manufacturing and final release of this specific lot.Trend search was performed for the reported issue and product.Based on the sales figures of the last 12 months, no systemic issue could be determined.The reported failure was identified as part of the current risk management file (dms #1464420 v15) and the most probable causes are associated with wrong design and lack of information.Mitigations for these specific failures are in place in instruction for use and in design measurements.Design measure: the used adhesives of the quadrox-i-id small adult / adult shall be compatible with the used materials to avoid mechanical damages (e.G.Cracks).The quadrox-i-id small adult / adult shall contain fibers that withstand intended use conditions, hence have no leakage during the intended application period.Instruction for use: warning! oxygenator leaks and damage.Can lead to infections, blood loss and embolisms in the patient.Before priming the oxygenator, run water through the heat exchanger and check for leaks on the blood side while priming.Check the oxygenator for leaks on the blood-carrying side while priming.Do not use the oxygenator if there are any leaks.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: OXYGENATORS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8798014
• MDR Text Key: 151301896
• Report Number: 8010762-2019-00214
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2020
• Device Model Number: QUADROX-I ADULT (VKMO)
• Device Catalogue Number: 70106.7942
• Device Lot Number: 92261425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Date Manufacturer Received: 10/15/2019
• Patient Sequence Number: 1