MAUDE Adverse Event Report: PLUM 360¿ INFUSER COMPATIBLE WITH ICU MEDICAL MEDNET¿ SOFTWARE; PUMP, INFUSION

Catalog Number 300105413

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Investigation is pending.

Event Description

The event involved a plum 360 infusion pump that the customer reported a delivery issue.The pump settings were for total parental nutrition (tpn) with a volume of 2 liters of fluid to infuse at 83 ml/hr that was initiated at 14:30 pm on (b)(6) 2021.The infusion was to run for 24 hours.The delivery issue was noticed at 9:30 am on (b)(6) 2021 when the pump alarmed with what the staff feels was an air in line (ail) alarm.All of the tpn was delivered to the patient and the bag was empty.The customer reported the tpn solution bags are covered with a red non-transparent bag to protect the nutrients, impossible for the staff to see if the bag was running low during infusion.The patient did not alert the healthcare professional of the event.There was no difficulty in programming or initiating the infusion.There was patient involvement, however, no harm, no adverse event, and no medical intervention to the patient was required.

Manufacturer Narrative

Pump was powered on and alarm logs reviewed.The pump passed full pvt testing without any alarms.The device worked as design and passed all final testing.Device logs were downloaded and sent off for review per instruction.Conclusion: the volume infused was consistent with the initial programmed rate and vtbi and the various titrations that were used before the proximal ail alarm stopped the therapy.The fact that the source container ran dry before the original therapy programmed for 24 hours expired is due to a 21 minute titration at a rate of 999 ml/hr which is over ten (10) times faster than the originally programmed rate of 83 ml/hr.About 450 ml was delivered in about 21 minutes with the 999 ml/hr rate.This would have taken 450/83 = 5.4 hrs to delivery at the original rate of 83 ml/hr.The pump was not programmed correctly by the user as it was found that in log review that a 999ml/hr rate was incorrectly programmed causing the container bag to run dry quicker than expected.

• Brand Name: PLUM 360¿ INFUSER COMPATIBLE WITH ICU MEDICAL MEDNET¿ SOFTWARE
• Type of Device: PUMP, INFUSION
• MDR Report Key: 12335464
• MDR Text Key: 267032113
• Report Number: 9615050-2021-00117
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Public: ++M33530010541316$$+740401875/16D20190827
• Combination Product (y/n): N
• PMA/PMN Number: K161469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300105413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2021
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/18/2021
• Supplement Dates Manufacturer Received: 08/23/2021
• Supplement Dates FDA Received: 09/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2019
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: PLUMSET, ICU MED LN14001 LOT 5180762; TOTAL PARENTAL NUTRITION, MFR UNK; PLUMSET, ICU MED LN14001 LOT 5180762; TOTAL PARENTAL NUTRITION, MFR UNK