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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRADIMED CORPORATION MRIDIUM 3861 SIDECAR SECOND CHANNEL (INFUSION PUMP); PUMP, INFUSION

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IRADIMED CORPORATION MRIDIUM 3861 SIDECAR SECOND CHANNEL (INFUSION PUMP); PUMP, INFUSION Back to Search Results
Model Number 3861
Device Problems Device Alarm System (1012); Break (1069); Difficult to Open or Close (2921); Protective Measures Problem (3015)
Patient Problem Hyperglycemia (1905)
Event Date 05/25/2022
Event Type  malfunction  
Event Description
There were multiple events on the same patient that happened with the same type of mri pump.The issues ranged from the door not being able to be closed, the pump not alarming when changing to tko (to keep open) mode.Pumps were alarming "occluded' with no apparent occlusion and no way to verify if the patient was getting the critical medication.Patient needed to go to mri, so mri pumps were obtained and primed by the previous shift.The bedside nurse asked various nurses for assistance with the mri pumps secondary to her unfamiliarity with the pumps and the constant alarming.There were multiple events where the pump that malfunctioned, was broken, or altered to create an unsafe patient care experience that required the administration of epinephrine, initiation and increasing titration of an epinephrine infusion, fluid bolus, and discontinuation of insulin all while the patient was off-unit and mid-procedure.Event 1: patient who was on an insulin drip stopped receiving dextrose-containing maintenance fluid.Blood glucose dropped from 300's to 140 upon discovery.Maintenance fluid containing dextrose has been part of the patient's care plan.Patient has been on an insulin drip requiring titration for high blood sugars.The patient needed to go to mri so all familiar drug administration set-up was replaced with an mri-compatible set-up.Mri pump stopped infusing at programmed rate and switched to tko (low infusion rate of 1ml/hr to keep line patent) without alarming or notifying user of change.The patient's blood sugar dropped significantly as the 20% dextrose maintenance fluid rate automatically switched to 1ml/hr instead of 100ml/hr and patient still continued to receive insulin.Event 2: pump read "occluded" and insulin was not being delivered.Night shift rn had prepared mri pumps for early mri trip.I came in to break the dayshift nurse for break and heard intermittent light beeping from the mri pump.After investigating, i noticed that the insulin had not been infusing and had been on standby.When the nurse came back from break, i asked if the insulin should have been running and she said that indeed it should have.We started the insulin and over the course of the next hour, the pump kept alarming "occluded".Line was double-checked for patency and there was no issue.Multiple nurses had checked as well until the decision was made to change the pump.The pump new pump worked and insulin finally was being infused appropriately prior to going down to mri.When the pump alarms "occluded", you cannot continue until you hit "silence".When you do hit silence, the pump automatically puts the infusion on standby instead of delivering the drug.I believe that the pump had alarmed occluded and someone probably hit "silence" but did not realize that the pump stopped infusing after that.I believe that it is because we found it on standby and clicked resume, that we discovered the constant occlusion alarm and finally switched the pump out.Event 3: patient was not receiving appropriate epinephrine infusion because the pump kept stopping delivery to alarm "occluded." the patient was off-unit and required fluid boluses while the problem was being resolved.Intermittent epinephrine was being delivered and the infusion was titrated upwards.At the time, it was unclear whether or not the patient was truly receiving the infusion of epinephrine.Patient needed to go to mri, but went to ir first for an hd catheter placement.In ir, the patient needed epinephrine.The mri pump kept alarming occlusion.I came downstairs with a new epinephrine syringe, mri tubing, and an mri pump with two channels.When i got to ir, we switched out the previous epinephrine syringe with the new set-up.However, the new set-up also alarmed occluded so i removed the tubing and went to put it in the other channel.Upon attempting to do so, the other channel on that new pump was broken.The door would not close completely and as such, the drug would not infuse.All lines were unclamped.The valve was opened.Other meds running in the same manifold were infusing just fine on the mri pump.The pump itself appeared to be the issue.We went to mri, during which i constantly restarted the epinephrine drip when it alarmed to ensure delivery.A total of three pumps were too broken to safely administer epinephrine.When we got to mri, the mri nurse grabbed a new pump from their own supply and i programmed the epinephrine on their pump.It worked.Proving that the issue was the three previous pumps and not the line itself.Event 4: patient was not receiving continuous insulin infusion.Patient has been on an insulin drip requiring titration for high blood sugars.The patient needed to go to mri so all familiar drug administration set-up was replaced with an mri-compatible set-up.The mri pumps stopped delivering dextrose maintenance fluids at the programmed rate, and when this was discovered, the md asked the rn to adjust insulin programming.Upon attempting to change the insulin, i found that the mri pump stopped infusing insulin at the programmed rate and switched to tko (low infusion rate of 1ml/hr to keep line patent) at some unknown time, without alarming or notifying user of change.(i say this to be a relief as the patient's blood sugar had dropped dramatically from the 300's to 140 after the maintenance fluids stopped delivering).The mri nurse said that if the volume to be infused has been achieved, the mri pumps switch to tko automatically, which can easily go unnoticed.Pumps were sent to clinical engineering and biomed team for evaluation.These events caused minimal temporary harm to patient.
 
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Brand Name
MRIDIUM 3861 SIDECAR SECOND CHANNEL (INFUSION PUMP)
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
IRADIMED CORPORATION
1025 willa springs dr
winter springs FL 32708
MDR Report Key14674145
MDR Text Key293834832
Report Number14674145
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3861
Device Catalogue Number3861
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/06/2022
Date Report to Manufacturer06/13/2022
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age6205 DA
Patient SexFemale
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