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

Model Number SET W/ QUADROX OPEN/CLOSED

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/04/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

''oxys were used in an operation and have poor oxygenation.'' customer complaint number: (b)(4).

Event Description

Complaint # (b)(4).

Manufacturer Narrative

The complained products were requested for the sample investigation.Two oxygenators (hqv 0737 # hlm - set mod.Tübingen cormed) were delivered as complaint samples.The oxygenators were cleaned with sodium hypochlorite and disinfected with incidin liquid.Visual inspection and a leak test according to local procedure lv 201 (blood side) were performed.During the leak test , a leak was found at the hose connection, at the blood inlet connector of the oxygenator 1.Also, it was found that the oxygenator 2 was damaged (cracked).No damage or leakage was reported from the customer.The found damages may have occurred during the shipment of the product to the maquet cardiopulmonary laboratory.No pressure abnormalities were found in the function test using a roller pump.Trend search was performed and no systemic issue could be found.Device history record review for complaint (b)(4) and lot 70129356 was performed.There were no references found which are indicating a nonconformance of the product in question.The device was manufactured in compliance with defined production steps and specifications.Appropriate manufacturing documentation and production step controls were in place.Therefore no manufacturing problem was detected.The reported failure was identified as part of the current risk management file (dms #1464420 v15)mitigations for this specific failure are in place as per design specifications and in instruction for use.Mitigation-112/ instruction for use: a pressure drop on the oxygenator can be a sign of reduced performance.This can lead to inadequate patient support monitor the pressure drop by measuring the pressure upstream and downstream of the oxygenator.Consider replacing the oxygenator if the pressure drop is significant.Check the gas exchange rate using blood gas analyses.Prepare to replace the oxygenator.Mitigation-061/ design.The surfaces of the quadrox-i-id small adult / adult with blood contact shall consist of hemocompatible material according to din en iso 10993-4.In order to investigate the issue and identify any product problem, relevant questions were asked.The perfusion protocol and the available information has been shared internally with getinge therapy application manager.It was stated that " the heparin administration was done because of a hospital standard related on time (the whole case was 5h).If the lowest heparin dose according to standard was given initially (300iu/kg) and 10000iu have been in the priming, 31600iu were active in the circulating blood.The halftime of heparin is 90min.So the measured act does not correlate with the amount of heparin circulating in the blood over the whole time of the perfusion.The anti-thrombin value is unknown.'' because of lack of information, it can not be fully determined whether it is user related.Therefore the claim by the clinic that the device has caused oxygenating problems cannot be nullified.The failure could be confirmed.However, the exact cause of the failure could not be identified.The reported failure did not contribute to death or serious injury.In addition at this time it cannot be concluded that this is a systemic error.Thus, no remedial action is required.No corrective actions are required.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.

• 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: 9438814
• MDR Text Key: 169920361
• Report Number: 8010762-2019-00375
• 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: 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SET W/ QUADROX OPEN/CLOSED
• Device Catalogue Number: 70106.5907
• Device Lot Number: 70129356
• Date Manufacturer Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1