MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUM A+ (11.3 VERSION) NEW RESTART; PUMP, INFUSION

Catalog Number	123918805
Medical Device Problem Codes	Inaccurate Flow Rate (1249); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion of the customer protocol test: the device was programmed on channel a to deliver a volume of 500 ml in 12 hours 30 minutes, at a flow rate of 40 ml/hr, resulting in 506 ml delivered in 24 hours 25 minutes.500 ml *5% = (+/- 25 ml) with a tolerance of +/- 5%.The delivery value was found to be within the allowed range.The delivery error margin was + 6 ml.According to the customer's experience, the device generated an excess supply in 1 hour of 500 ml.However, the customer's protocol tests determined that the device worked 24 hours 25 minutes without interruption and the infusion was completed without over-delivery or alterations of the values.Delivering what was programmed.A keyboard test was performed to verify that it did not self-program.Each key works correctly, the test passed correctly.It can be concluded that during the customer protocol and product verification tests, the device infused correctly without over deliveries, did not generate technical faults or alarms or overprogramming caused by the keyboard.Probable cause: it cannot be determined if it was a user error since no events were found with programming with a rate of 47 ml/hr or programmed deliveries at 500 ml volume.According to the customer report, the device was not segregated at the time of the event and later more infusions were programmed with other medications, possibly erasing the events related to the case that occurred with the patient.Initial reporter full phone number: (b)(6).Model number is not sold in the us but similar device is sold under model number 123918805.This product's model number was used for the di and the 501k.
Event or Problem Description
The complaint/event involved a plum a+ (11.3 version) new restart.It was reported that a potassium chloride drip was installed (not labeled on the pump).A total volume of 500 ml was installed at 40 cc/h, and it was reported that in 01 hour the total volume of 500 ml was infused.This occured between 9:00 p.M.And 12:00 a.M.The infirmary reported that the infusion rate was displayed at 47 cc/h.The message "cassette error" was displayed, but subsequently other medications continued to be infused, for which no message was displayed.There was no clinical alteration in the patient after the event and unspecified pertinent measures were taken.

• Brand Name: PLUM A+ (11.3 VERSION) NEW RESTART
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20006413
• Report Number: 9615050-2024-00618
• Device Sequence Number: 4343477
• Product Code: FRN
• UDI-Device Identifier: M3352079204251
• UDI-Public: M3352079204251
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K070398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/19/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 123918805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Initial Report FDA Received Date: 08/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: POTASSIUM CHLORIDE, MFR UNK.
• Patient Age: 88 YR
• Patient Sex: Female