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

Model Number QUADROX-I PEDIATRIC (VKMO) W/ FILTER

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

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

Event Date 01/07/2020

Event Type  malfunction  

Event Description

According to the customer, 'during pediatric open heart surgery, while using the quadrox ventilation lung vkmo-31000, there was a blood leak around the root of the connector on the blood sending side.The operation was completed without any blood leaks, but the cause was investigated and reported.' (b)(4).

Manufacturer Narrative

The product was requested for investigation in the laboratory of manufacturer on 01/09/2020.Visual inspection and leak test per local procedure lv 201 were performed.Hairline cracks were detected at the luer lock connector on the outlet side.Based on this, failures could be confirmed.Trend search was performed.6 additional complaints were recorded in the last 12 months.The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Thus, no remedial action required.A review for potential fscas related to this complaint was performed.The product in this complaint is not in scope of any fsca.No nc/capa record was found related to this failure for this affected component.Device history records for lot: 92250720 and 70122056 were reviewed.There were no references found, which are indicating a nonconformance of the product in question.The reported failure was identified as part of the current risk management file (dms#: 1448129 v18 ).Mitigation's for this specific failure are in place as per instruction for use warnings and design specifications.The manufacturer`s review of the control form in production indicated that a 100% visual inspection for deformation is conducted during manufacturing.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing and therefore all damages found on the product are due to excessive or inadequate external physical force that was exerted on the product after the release.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

Complaint: (b)(4).

• Brand Name: OXYGENATORS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9617229
• MDR Text Key: 190536072
• Report Number: 8010762-2020-00030
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• 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: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2020
• Device Model Number: QUADROX-I PEDIATRIC (VKMO) W/ FILTER
• Device Catalogue Number: 70106.3849
• Device Lot Number: 92250720
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1