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

Model Number CARDIOHELP-I

Device Problems Electrical /Electronic Property Problem (1198); Leak/Splash (1354); Loose or Intermittent Connection (1371); Failure to Pump (1502); No Flow (2991); Noise, Audible (3273)

Patient Problem Low Oxygen Saturation (2477)

Event Date 11/12/2021

Event Type  malfunction  

Event Description

Pt required circuit change after blood products, low flows and off anticoagulation.Cardiohelp ecmo machine was brought into the room in preparation for circuit change.The nurses noted an ac power voltage error that eventually resolved after trying multiple red outlets.The rpms increased approp.On machine when turned up and so circuit change was started.Wet to wet underwater connections performed without any problems and no air was noted in line.Cardiohelp was increased to 4 liters of flow on ecmo and good color change was noted.Then we noted a small stream of air foam in the access and return lines.We then heard the motor of the cardiohelp grinding air and ecmo flows dropped to 0.1.Rn noted 3 way stopcocks to be loose and tightened them and pulled air out of the top of the oxygenator in access 3 way p2 and p3.We still had poor flows.The global override was turned off and the arterial bubble alarm sounded and then flow went to zero.Pt sats went from 80's down to 40's we emergently switched the oxygenator to the hand crank and were able to hand crank the machine and maintain sats at 100%.At one point there was also a pump failure alarm that went off but i won't know if that was because the oxygenator had been moved to the hand crank.I left and worked to prime and clean the novalung, and another staff member tried to re-attach the oxygenator and re-zero the flow probe, and bubble detector without success.The doctors and nurses hand cranked the machine for approx.1 hour while i primed the novalung ecmo circuit.We then preformed another circuit change without complications.I cleaned and primed the possibly defective cardiohelp because there was no backup ecmo machine and circuit ready for any of the ecmo patients should one be needed emergently.I did not note any alarms or problems with machine while priming.We attempted to rent a replacement cardiohelp so we could send the one we had to biomed for investigation.

Event Description

Pt required circuit change after blood products, low flows and off anticoagulation.Cardiohelp ecmo machine was brought into the room in preparation for circuit change.The nurses noted an ac power voltage error that eventually resolved after trying multiple red outlets.The rpms increased approp.On machine when turned up and so circuit change was started.Wet to wet underwater connections performed without any problems and no air was noted in line.Cardiohelp was increased to 4 liters of flow on ecmo and good color change was noted.Then we noted a small stream of air foam in the access and return lines.We then heard the motor of the cardiohelp grinding air and ecmo flows dropped to 0.1.Rn noted 3 way stopcocks to be loose and tightened them and pulled air out of the top of the oxygenator in access 3 way p2 and p3.We still had poor flows.The global override was turned off and the arterial bubble alarm sounded and then flow went to zero.Pt sats went from 80's down to 40's we emergently switched the oxygenator to the hand crank and were able to hand crank the machine and maintain sats at 100%.At one point there was also a pump failure alarm that went off but i won't know if that was because the oxygenator had been moved to the hand crank.I left and worked to prime and clean the novalung, and another staff member tried to re-attach the oxygenator and re-zero the flow probe, and bubble detector without success.The doctors and nurses hand cranked the machine for approx.1 hour while i primed the novalung ecmo circuit.We then preformed another circuit change without complications.I cleaned and primed the possibly defective cardiohelp because there was no backup ecmo machine and circuit ready for any of the ecmo patients should one be needed emergently.I did not note any alarms or problems with machine while priming.We attempted to rent a replacement cardiohelp so we could send the one we had to biomed for investigation.

• Brand Name: MAQUET CARDIOHELP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 13534265
• MDR Text Key: 285612983
• Report Number: 13534265
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARDIOHELP-I
• Device Catalogue Number: 70107.2780
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2021
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 10220 DA
• Patient Sex: Male