MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number VKMO 71000

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"pediatric quadrox-i oxygenator leaked at the luer connector on the membrane part.The product, listed below, during the patient's cpb at the time of surgery, had to change three oxygenators due to the oxygenator preventing the flow and oxygenation of the blood, showing a dark red color.Severe patient in icu, already presenting reinfections and 4th reop with all valvular dysfunction, aortic, mitral, tricuspid and endocarditis.Patient was in isolation by the clinical staff.Suspected team reported - severe coagulation disorder.It was questioned the blood typing and the experience of dr.(b)(6), unlikely problem in the disposable." complaint: #(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary requested the product back for investigation however it was scrapped by customer.Therefore no technical investigation could be performed.In addition, device history record could not be reviewed since serial numbers on the product are not available.The cause of the failure could not be identified.Trend search was performed for reported issue and similar product.Additionally 10 complaints were recorded which appears reported issues are the same.(b)(4).Due to this information no systemic issue could be determined at this time.Trend search shows that 7 complaints found not product related, 2 complaints are not closed yet and 1 complaint sample shows clots.In this complaint, no clots were reported.Therefore, at this time no similar complaint investigated was found which could led to the confirmation of the failure and / or a product related malfunction.Based on this failure could not 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 to lack of information on pressure drop / pressure increase and manufacturing process.Mitigations for this specific failures are in place as per instruction for use and basic operation procedures, product specifications related with equipment, defined production steps and specifications, in process controls, final inspections and visual inspections during the manufacturing process.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: QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9201159
• MDR Text Key: 200639377
• Report Number: 8010762-2019-00328
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2020
• Device Model Number: VKMO 71000
• Device Catalogue Number: 70106.7949
• Device Lot Number: 92272770 / 92272823
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2019
• Patient Sequence Number: 1