MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLM A+ FRENCH VII (REFURB); PUMP, INFUSION

Catalog Number 123912902

Device Problems No Audible Alarm (1019); No Flow (2991)

Patient Problems Necrosis (1971); Swelling/ Edema (4577)

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.The investigation is pending.

Event Description

The product involved is a plum a+ infusion pump where the customer reported that the pump did not alarm and did not display any message on the screen for the detected occlusion during infusion by the nurse.There was patient involvement and the patient had edema on the right arm with skin necrosis.There was unspecified medical intervention and care, but there was no delay in critical therapy.The patient state before, during and after the incident did not change.It remained stable.The pump did not present any delivery issue, there was no impact of force on the pump and no physical damages noted.

Manufacturer Narrative

The reported complaint was ¿the pump did not alarm and did not display any message on the screen for the detected occlusion by the nurse¿ and was investigated.The entire logs were reviewed/downloaded and attached to the service request.Time period: (b)(6) 2023, no major alarms were found in log.The following was noted in the ¿as found condition¿: device has damaged cases/door assembly/fluid shield.The device failed inspection due to as found condition but passed all performance verification tests (pvt) without any issue.The device was run-in on channel-a at rate: 7.8 ml/hr for volume to be infused (vtbi): 130 ml.The device completed run-in without any issue.The complaints were not confirmed since no problem was found so a probable cause could not be determined.Probable cause for damaged cases/door assembly/fluid shield.Is damaged parts.

• Brand Name: PLM A+ FRENCH VII (REFURB)
• Type of Device: 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: 18062519
• MDR Text Key: 327270282
• Report Number: 9615050-2023-00599
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Public: +$$+775280051/16D20060411
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K070398
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 123912902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2006
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1