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

Model Number 70105.0109

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/09/2019

Event Type  malfunction  

Manufacturer Narrative

The product is not available for investigation.Therefore no technical test could be performed on the device in the laboratory of manufacturer.However a video was received from customer which shows the leakage at the de-airing membrane part of oxygentaor with the yellow cap (pos.2).Therefore the reported failure could be confirmed.The reported failure was identified as part of the current risk management file ((b)(4)) and the most possible root causes are associated to wrong design 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 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 treatment is responsible for the procedure and correct use of the device.The applications must be performed as per proven clinical guidelines.The exact cause of the failure could not be identified.In addition the device history records for complaint (b)(4) and lot 70119915 and 92236465 have been reviewed.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.Based on the sales figures of the last 12 months following occurrence rate has been calculated and it has been found below than 1%.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 (b)(4) and further investigations and measures will be conducted in case of adverse trending.

Event Description

"leakage from the top of oxygenator." the de-airing membrane with yellow protective cap is leaking.Complaint: #(b)(4).

• Brand Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 9368813
• MDR Text Key: 200666146
• Report Number: 8010762-2019-00370
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/25/2019
• Device Model Number: 70105.0109
• Device Catalogue Number: VKMO 10000
• Device Lot Number: 92236465 / 70119915
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/11/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1