MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG CATHETER, CARDIOPULMONARY BYPASS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 10031#AVALON ELITE

Device Problems Suction Problem (2170); Device Displays Incorrect Message (2591); Gas/Air Leak (2946)

Patient Problems Pulmonary Embolism (1498); Contusion (1787); Hemorrhage/Bleeding (1888); Heart Failure (2206)

Event Date 12/11/2018

Event Type  Death  

Manufacturer Narrative

The product was requested for return to the manufacturer for laboratory investigation but was not received yet.The investigation is still pending.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

Internal reference- (b)(4).Calls night over the hotline with mrs.(b)(6): on (b)(6) 2018.First call of medical intensive at 3:14: inquire if they could get a new avalon cannula because there is air in the system.On demand, both venous and arterial air bubbles and bladder alarm associated with "less" blood flow.Recommendation to stop system directly! demand, where from air, e.G.Zvk., which she did not know.Demand for stability patient, umkanülierung, since new avalon min.3 std needed.She would consult with oa and possibly report again.Second call from medical intensive at 4:04 am: oa would like to have the 31 fr avalon cannula.Please order for delivery! system was still on.Another recommendation to stop it.On demand blood flow at 0.28 lpm (= 0 lpm).Demand if no cannulation with 2 cannulas is possible for transitional period; according to femoral cannulation is not possible.On (b)(6) 2018 call from dr.(b)(6) at mr (b)(6) at 9:44 am: call back at 11: 31h.Questions, debriefing of the incident: pat died in the night.(b)(6) due to bleeding after tracheostomy.The police confiscated the corpse with a lying avalonkanüle, cardiohelp and all documentation sheets.According to dr.(b)(6) pat had a car accident pulmonary embolism, pulmonary contusion, right heart failure, cannulation with a 31 fr.Avalonkanüle right jugular.According to dr.(b)(6) was pulled after the plant for the first time on the venous side air, system was clamped and stopped, air removed, system restarted, suction problems were present, after volume improvement, at 2000rpm but only 500ml bf.Oxygenation of the pat also improved under this minor support.At night.Again air in the system.:possible causes discussed: needles (b)(6) excluded.Material mistake" lutfbildung due to gravity, zvk.The avalonkanüle is not available to us for investigation, because everything was confiscated by the police."more detail information are requested" but still pending.Material and lot number "are" requested but currently not available.The second avalon cannula was not placed on the patient.

Event Description

Internal reference- (b)(4).

Manufacturer Narrative

Investigation summary complaint: (b)(4).Investigation results: the device history record (dhr) of lot # 214887 (p/n 10031 - 31 fr.Bi-caval dlc) was reviewed on 2020-03-02.No indication was found in regards to the reported failure.A review for capas and ncs related to the reported failure ¿air in the system¿ was performed on 2018-12-13 and 2020-02-20.Neither a capa nor nc was found.A trend search was performed on 2020-02-20 for the failure ¿air¿ and period from 2017-12-13 to 2020-02-20.Three additional complaints were recorded within that time frame.No additional complaint was found for lot # 214887.The following risk mitigation is covered under (b)(4) since 2016-09-21: "ifu warning: during tracheotomy there is a general risk of injuring the vessel (vena thyroidea inferior).When performing tracheotomy while the patient is on ecls, a vessel injury in the region of the ecls catheter may lead to bleeding and potential air entry into the catheter with following air embolism in the patient.Avoid tracheotomy if possible when 100 % ecls assistance is required- control coagulation status prior to intervention- if no contradictions exist, perform tracheotomy of the patient in head down position- perform ultrasound study of the thyreoid region and the region to identify vessels to avoid vessel injury." a medical review was performed by manager medical affairs on 2020-02-19: the clinical evaluation report is pointing out the following: ¿during tracheotomy there is a risk of vascular injury (inferior thyroid vein).If you perform a tracheotomy whilst the patient is connected to an extracorporeal life support system, vascular damage in the area of the catheter of the extracorporeal life support can result in bleeding and possibly the ingress of air into the catheter which, in turn, result in an air embolism in the patient.- avoid tracheotomies if full extracorporeal life support is required; - check the coagulation status prior to the intervention; - if no exclusion criteria apply, move the patient into the trendelenburg position and perform the tracheotomy in this position; - before making the incision, render the thyroid region visible by means of ultrasound in order to identify any vessels which may be in the way and thus to avoid vascular injury.R&d engineering provided a statement via email on 2020-02-28.Regarding the most probable root causes for ¿cracks¿ on the avalon cannula, : depending on the circumstances and clinical situation, there can be many different causes for the formation of cracks.However, i consider the causes for cracks to be usually due to improper handling of the cannulas.On (b)(6) 2020, dr.(b)(6) confirmed that: neither the cannula nor the oxygenator had a malfunction.Maquet product was functional during the treatment of the patient and the death of the patient was not product related.Based on the information available at this time the cause of the reported failure ¿air in the system¿ was determined to not be attributed to a device related malfunction.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: CATHETER, CARDIOPULMONARY BYPASS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8168944
• MDR Text Key: 130527698
• Report Number: 8010762-2018-00328
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 10031#AVALON ELITE
• Device Catalogue Number: 70106.3538
• Device Lot Number: 214887
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 12/17/2018
• Supplement Dates Manufacturer Received: 02/23/2020
• Supplement Dates FDA Received: 03/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death