MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH AVALON ELITE BI-CAVAL LUMEN CATHETER, 31 FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 10031#AVALON ELITE 31F, 31CM

Device Problem Improper Flow or Infusion (2954)

Patient Problems Death (1802); Bronchopneumonia (2437)

Event Date 12/02/2019

Event Type  Death  

Manufacturer Narrative

The sample was discarded by the hospital.

Event Description

It was reported that the customer had a patient with respiratory failure, they initially put in a 27 french (lot# 218747) on (b)(6) 2019 and it kept torquing so they changed it out to a 31 french (lot# 205257) on (b)(6) 2019, but it was extremely positional ¿ they had to put layers of 4x4s under the cannula to maintain flow at a steady level.Original cannula was placed using xray and replacement cannula was placed using fluoro.On 2020-02-06 further information was received: the patient expired.Ct of the head showed anoxic brain injury.The patient¿s official cause of death from autopsy was bronchial pneumonia ¿ lungs were described as completely fibrotic.Oxygen sats were low unless the cannula was manipulated.The cannula needed manipulation every few hours to maintain oxygen sats above 80.If the circuit tubing connected to the cannula was not repositioned the oxygen sats would decrease and the pao2 was low as well.With manipulation oxygen sats would increase to the 90¿s and pao2 would increase as well.On xray and ultrasound the cannula was always in the correct position.On the final autopsy result the cannula was determined to be in correct placement.Note: this complaint (31 fr cannula) is related to complaint # (b)(4)(27 fr cannula).Both complaints concern the same patient but different products.(b)(4).

Event Description

Internal ref.# (b)(4), onesupport # (b)(4).

Manufacturer Narrative

As the original cannula was already disposed an unused, similar cannula from the same lot was requested for further investigation in the laboratory of the manufacturer on 2020-02-20.The sample was received on 2020-05-04 and investigated in the laboratory on 2020-05-05.Results of laboratory investigation: the received avalon elite 31 fr was not in its original packaging.During visual inspection a kink at the junction of the two lines (inlet and outlet) was noted.The kink compressed the inner line (inlet).This damage was probably caused by packing in the biocontainer and transport.No further abnormalities were detected.For further inspection a medical review was performed by manager medical affairs on 2020-04-17: no information about blood flow, pressures, blood gas analysis, hematocrit / hemoglobin levels and anticoagulation was provided.Little information about the gas exchange was provided, this information is indicating difficulties to meet oxygen consumption of the patient.Between the initiation of the procedure on (b)(6) 2019 and the (b)(6) 2020 the clinicians experienced difficulties and reported that extra supports on the catheter and the corresponding circuit was required in order to prevent from recirculation or rather showed large position dependency.No information about skin fixation and suturing was forwarded by the customer that could support this evaluation.The clinicians decided to replace the device with a dlc (dual lumen catheter) with a larger diameter.It remains unclear whether edema or tuberous that declined or increased throughout the first weeks in the course of the procedure led to the claimed necessity of the ¿extra supports¿ around the catheter and the corresponding circuit.It is unknown whether a visual imaging technique and/or a blood gas analysis control have been conducted after every repositioning of the patient and the catheter.As the course of the ecc (extracorporeal circulation) run with the 27 fr device in scope took almost 3 weeks it is deemed that no malfunction of this catheter was given.It is also deemed that the final autopsy of the patient with the corresponding 31 fr device in scope would have identified a potential malfunction.An use error can neither be ruled out nor confirmed as insufficient data is available in order to assess.Thus no malfunction of the device could be confirmed.According to the risk assessment (elite-i dual lumen catheter, dms # (b)(4)) following probable root causes could lead to the reported failure: lack of catheter fixation , unintended repositioning of the catheter due to e.G.Patient transport or repositioning , repositioning without imaging methods , unintended movement and reposition due to removal of introducer or guidewire.When the event occurred, the device was being used for treatment of the patient.The product was directly involved in the incident.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.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: AVALON ELITE BI-CAVAL LUMEN CATHETER, 31 FR
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9749562
• MDR Text Key: 180708048
• Report Number: 3008355164-2020-00009
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 05/14/2020

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 31F, 31CM
• Device Catalogue Number: 701063538
• Device Lot Number: 205257
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2020
• Distributor Facility Aware Date: 02/03/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 05/05/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 33 YR
• Patient Weight: 105