MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH CARDIOHELP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number CARDIOHELP

Device Problem Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up will be submitted when additional information become available.Further information were requested, but not received yet.

Event Description

The following was reported: 2nd console (on which the defective circuit would not prime) s/n (b)(4).April 9th : " 4:30 am: intensivist fellow md prescribes 25 mg protamine." ~4:45 am: infusion of 25 mg protamine begins in peripheral venous cannula." ~5:00 am transmembrane pressures jump from 19 mmhg to 65 mmhg.Perfusionist calls the intensivists to warn them that the tmp were increasing.V.O.To halt the protamine infusion.Membrane is inspected, no signs of fibrin formation or clotting." 5:10 am transmembrane pressures continue to go up.65 ->85->100->120.Membrane is inspected again, still no signs of clotting on the post-membrane side.As i come around the other side to check on the transmembrane pressures on the screen, i notice an error message ¿erreur produit usage unique  arr¿t¿ and the flow is 0 lpm.I clamp the outflow line with my hands and try to increase the rpm to get forward flow again, but they fall back to 0 rpm.With help from nursing, we manage to get the 1st circuit onto the hand crank within 1 minutes (approximately) and begin cranking.Forward flow is established at 3.5 lpm and patient map and cerebral saturations were in the normal range." backup perfusionist is on site, and is called to bring backup ecmo circuit." discussion with intensivists.We told them we have two options: firstly, we can switch the 1st circuit onto another console and assess our options (not our ideal option since the transmembrane pressures are still high).Secondly, we can prime our backup circuit in order to change out the membrane.The perfusionists preferred changing out the membrane because they believed it would be the less risky option and would take the least amount of time." priming the 2nd circuit was unsuccessful.When the plasmalyte-a was dropped, we were unable to prime by gravity or by increasing rpms.Both perfusionists took turns manipulating the circuit to try to get it primed but to no avail.When the rpms were increased, the console would make a loud rumbling sound, much louder and more vibrations than if the membrane were decoupled, which the perfusionists accounted for by detaching and reattaching the pump to the console as well as reducing the rpm to zero." with intensivists, we decide to switch the original circuit (currently being hand cranked) to the second console.45 second circulatory arrest, and then flow was re-established, still with high tmp (around 175 mmhg at this point, but the pressures are not calibrated because it is now on the 2nd console)." one perfusionist goes to get a third console in the basement, and sets up a new circuit and primes it." setting up the patient for circuit change out.Surgical resident and intensivist are scrubbed in, and the change out happens at the bedside in the icu.50 second arrest time, and full flow is established immediately.The event will be investigated in further complaints: (b)(4).This emdr belongs to complaint number: (b)(4).

Event Description

The event will be investigated in further complaints:(b)(4).This emdr belongs to complaint number: (b)(4).

Manufacturer Narrative

The event occurred in canada.It was reported that the priming of the hls set was unsuccessful.When the plasmalyte-a was dropped, customer was unable to prime by gravity or by increasing rpm´s (round per minutes).Both perfusionists took turns manipulating the circuit to try to get it primed but to no avail.When the rpm´s were increased, the cardiohelp-i would make a loud rumbling sound, much louder and more vibrations than if the membrane were decoupled, which the perfusionists accounted for by detaching and reattaching the pump to the cardiohelp-i as well as reducing the rpm to zero.The set was not used for treatment.No indication of actual or potential for harm or death has been reported.The described priming issue will be handled in onetrack complaint (b)(4).This cardiohelp unit and the involved hls set were prepared for treatment because of an issue with a previous cardiohelp and hls set (handled under (b)(4)) the event is related with the following complaints: the first used hls set will be handled in complaint (b)(4).The first affected cardiohelp-i console with s/n (b)(6) will be handled in complaint (b)(4).The second affected hls set will be handled in complaint (b)(4).A getinge service technician investigated the unit in question within the preventive maintenance on 2021-07-06.The technician could not confirm the reported failure and the device was put back in use.The log files analysis was performed by life-cycle-engineering on 2021-08-24.The log files does not show any malfunction.However, it can be confirmed from the logs during the described period that work was done on the circuit, possibly an attempt was made to fix a problem of the disposable.An exact root cause could not be determined.As stated the circuit could not be primed (investigated under complaint#(b)(4)).A not fully primed centrifugal pump could cause noises while running.In the hls set instruction for use, chapter 5.3.2 "safety instructions for centrifugal pump" is stated to not start the centrifugal pump without liquids and before it is properly primed because this can lead to damages to the rotor bearing.Further it is noted that scratching noises can be a sing of a malfunctioning centrifugal pump.Based on the investigation results no malfunction of the involved cardiohelp unit could be confirmed.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: CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11730340
• MDR Text Key: 256214498
• Report Number: 8010762-2021-00271
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K133598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP
• Device Catalogue Number: 701048012
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2021
• Patient Sequence Number: 1
• Patient Weight: 60