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

Model Number 10031#AVALON ELITE 31F, 31CM

Device Problem Improper Flow or Infusion (2954)

Patient Problem Death (1802)

Event Date 02/03/2020

Event Type  Death  

Manufacturer Narrative

The sample is not available for return.

Event Description

This patient is a (b)(6) year old male with influenza a, the customer put him on support with a 31 french cannula.This cannula was placed using xray and ultrasound.The customer reported issues with the cannula being positional despite perfect placement.Further information received on 2020-02-06: "the (b)(6) year old male¿s cannula is now flowing without issues.There was a tee performed yesterday which showed the cannula is in perfect placement.All the extra supports i had placed on the cannula and circuit were removed the patient¿s head was turned side to side and the cannula did not move.Not sure why there were issues the first two days but now ¿ all resolved.¿ the customer stated on (b)(6) 2020: ¿our patient expired early this morning and i was not able to retrieve the cannula.¿ (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 investigation a medical review was performed by manager medical affairs on 2020-04-17: the large position dependency with respect to the corresponding flow across the catheter could point to a mismatch between the vascular status and the 31 fr dlc (dual lumen catheter) device in question.The physician(s) in charge may have carefully considered, but probably came to the conclusion that the next smaller size of the avalon dlc would not provide sufficient blood flow and thus oxygen delivery shortage and/or carbon dioxide elimination shortcoming.Between the initiation of the procedure on (b)(6) 2020 it has been reported that the extra supports on the catheter and the corresponding circuit were no longer needed and therefore have been removed.But, unfortunately there are no information about skin fixation and suturing gathered that could support this evaluation.According to the report the clinicians seemingly had difficulties with the position dependency and torqueing.Edema or tuberous that declined or increased throughout the first 2 to 3 days in the course of the procedure could have led to the claimed necessity of the ¿extra supports¿ around the catheter and the corresponding circuit.Although it was reported to have gained the ¿perfect placement¿ of the device vasoactive drugs could led to (intermittent) consecutive vasoconstriction that stuck the catheter within the venous vessel ¿ potentially in an unfavorable position.Diuretic drugs also could have amplified a ¿shrinking¿ of the surrounding vascular structure or the skin fixation that also could have promoted the situation.It is unknown whether a visual and/or a blood gas analysis control have been conducted after every repositioning of the patient and the catheter.The mentioned heart failure, as the cause of death, could be a complication stemming from the influenza disease or the patient did suffer already from a heart failure that accumulated during the procedure.A 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.The most probable root cause is a mismatch between the interacting venous vessel walls and the catheter in scope.In addition to that according to the risk assessment (elite-i dual lumen catheter, dms #2041198 v04) following probable root causes could also 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.

Event Description

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

• Brand Name: AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 31FR
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9749560
• MDR Text Key: 180708134
• Report Number: 3008355164-2020-00010
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Weight: 126