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

Model Number BO-HQV 51601

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) did not request the product back for investigation since there is a similar complaint, which shows a similar malfunction has been already investigated in #(b)(4): quadrox-i adult was received on 2019-09-23.Biological residuals were observed on the sample and therefore the device was submitted to a cleaning process using sodium hypochlorite as per local procedure lv 205.After the cleaning process, the device was submitted to a visual test and leaking test.In visual inspection, no identifiable defect was found.The leaking test on the blood side connection of the device was performed on 2019-10-23 according to test method lv 201 and a leakage from the dialysis lock and valve was detected.Therefore the reported failure could be confirmed.Trend search was performed for this component and reported failure.Based o the sales figures of the last 12 months following occurrence rate has been calculated and found below 1%.Due to this information no systemic issue could be determined.Maquet cardiopulmonary (b)(4) has already initiated a corrective and preventive action (capa) process based on several complaints showing the same symptoms with different material numbers than the one in this complaint, in order to determine the root cause and initiate further actions to determine corrective measures for the failure.Root cause analysis was already completed and actions are in implementation phase.All further steps will be performed in accordance to capa.The reported failure was identified as part of the current risk management file ((b)(4)) and the most possible root cause is associated to wrong design.Mitigation for this specific failure is in place per design specification: the dialysis lock connector and corresponding components of the quadrox-i-id small adult/adult shall be of appropriate dimension to enable a stable and non leaking connection.There is an engineering change request regarding design change of dialysis-valve to improve the sealing properties of the dialysis-valve.In addition the device history record for complaint (b)(4) and lot 70131540 and 92266317 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.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

During cardiopulmonary bypass surgery leakage from the dia-connector of oxygenator was found.Not seen during priming.The port was not used.Complaint: #(b)(4).

• Brand Name: OXYGENATORS
• 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: 9392254
• MDR Text Key: 200679190
• Report Number: 8010762-2019-00376
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2021
• Device Model Number: BO-HQV 51601
• Device Catalogue Number: 70104.1635
• Device Lot Number: 92266317
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1