MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM 360¿ INFUSER; PUMP, INFUSION

Catalog Number 300100481

Device Problems Failure to Infuse (2340); Pressure Problem (3012)

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); High Blood Pressure/ Hypertension (1908); Low Oxygen Saturation (2477)

Event Date 03/01/2023

Event Type  Injury  

Event Description

The event occurred on an unspecified date and involved a plum 360 pump.It was reported there were distal occlusion alarms in the nicu and picu.The patient was on continuous renal replacement therapy (crrt) and extracorporeal membrane oxygenation (ecmo) for refractory septic shock.The patient had a sudden heart rate drop to 32-34 and hypertension with loss of oxygen saturation and a rapid spike in blood pressure.A code blue was initiated, and compressions performed.During the episode the plum 360 pump alarmed for distal occlusion.The patient was on inotropic and sedation drips.The pump read ¿infusion stopped/back prime prior to restart.¿ the nurses were unable to clear alarms to get the pump to infuse by back priming.Lines re primed and attempted to restart, though same alarms continued to alarm.Switched all drips to alaris pumps due to excessive amount of time required to clear alarms and patient not receiving critically necessary drips while troubleshooting.Ended up switching all drips to alaris.Reporter stated that the nipride drip ran out causing the patient¿s blood pressure to spike and may have caused back pressure on the pumps, possibly causing it to start alarming.After the reported event, the patient was stabilized, and therapy was resumed on a alaris pump.The plum pumps were placed back into circulation the following day.

Manufacturer Narrative

The customer indicated that the device is not available for investigation.However, a comprehensive investigation has not yet been completed.

Manufacturer Narrative

This is a general complaint, where no device was returned to the service hub for analysis and evaluation.Therefore, no visual inspection and functional testing were performed to determine if the device played a role in the adverse event.The 12-month service history could not be reviewed as the customer did not provide the serial number of the pump.Gcm reached out to the customer for the service repair history, but no information was provided.Event logs were not provided.Conclusion: in conclusion, since the device was not returned to the service hub for analysis and evaluation, no visual inspection and functional testing were performed to determine if the device had a role in the adverse event.

• Brand Name: PLUM 360¿ INFUSER
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16755667
• MDR Text Key: 313448067
• Report Number: 9615050-2023-00112
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300100481
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: EPINEPHRINE, UNK MFR; FENTANYL, UNK MFR; NIPRIDE DRIP, UNK MFR; NITROPRUSSIDE, UNK MFR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 9 YR
• Patient Weight: 45 KG