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

Model Number QUADROX-I PEDIATRIC (VKMO)

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

''whilst on bypass there was a leak noticed from the de airing port of the oxygenator see video.Case carried on as normal oxygenator was not changed out during procedure.'' customer complaint number :(b)(4).

Manufacturer Narrative

Getinge cp did not need to request the product back for manufacturer laboratory investigation.The received video from the customer shows the leakage at the de-airing membrane part of oxygenator with the yellow cap.In addition, maquet cardiopulmonary ag is aware of similar complaints from a similar product.Similar products, showing a similar malfunction, have been investigated in #(b)(4): leakage at the venting membrane can be confirmed.Therefore the reported failure could be confirmed.The reported failure was identified as part of the current risk management file (dms#(b)(4)) and the most possible root causes are associated with component selection and user error.Mitigations for this specific failure are in place as per mitigation-124 design specification and mitigation-076 ifu warning.Mit-124: design specification: the de-airing port of the quadrox-i neonatal/pediatric shall allow sufficient de-airing without allowing blood to exit.Mit-076: ifu warning: a lack of knowledge on the use of the device can result in serious injuries to or death of the patient.- the device may only be operated and monitored by qualified medical staff.- the device may only be operated by staff specially trained in the field of extracorporeal circulation.- the physician in charge of the treatment is responsible for the procedure and correct use of the device.- the applications must be performed as per proven clinical guidelines.In addition, the device history records for complaint (b)(4) and lot 70119912 have been reviewed.There is no evidence indicating a nonconformance or deviations of the product in question during the manufacturing and final release of this specific lot.A trend search was performed.Based on the sales figures for the last 12 months following occurrence rate has been calculated and it has been found below than accepted rate.Due to this information, no systemic issue could be determined at this moment.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.

Event Description

Customer complaint number :(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9415703
• MDR Text Key: 200414020
• Report Number: 8010762-2019-00382
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QUADROX-I PEDIATRIC (VKMO)
• Device Catalogue Number: UNKNOWN
• Device Lot Number: 70119912
• Date Manufacturer Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1