MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. POMPE À PERFUSION PLUM 360¿, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDNET¿; PUMP, INFUSION

Catalog Number 300102913

Device Problems Failure to Sense (1559); Improper Flow or Infusion (2954); Pumping Problem (3016)

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

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event occurred on an unspecified date and involved a pompe à perfusion plum 360¿, compatible avec le logiciel icu medical mednet¿.The following issue was reported by the customer: ¿missed occlusion¿.There was no human harm reported as a result of this event/complaint.

Manufacturer Narrative

The customer's complaint was investigated and testing was performed on the pump.The logs were reviewed.Time period: 21-jun-2023 to 25-jul-2023, seven entries of n185 (peak proximal occlusion a non-delivery) were identified on 25-july-2023.The probable cause for the identified error codes could not be determined.Although the pump failed visual inspection due to a cracked rear case/door assembly, the device passed occlusion testing without issue.The pressure detector will be recalibrated as a precaution during repair.D9 - date returned to mfg: 14aug2023.

Manufacturer Narrative

The complaint investigation was updated on 03oct2023 to include the following information: in addition to the the device passing the occlusion testing without issue during the complaint investigation, the infusion pump device also passed all testing, including a full performance verification testing (pvt) without any issue.The device alarmed audibly when expected during occlusion tests.The complaint could not be confirmed through testing or through alarm logs review.No probable cause for the customer's reported issue could be determined.

• Brand Name: POMPE À PERFUSION PLUM 360¿, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDNET¿
• 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: 17486902
• MDR Text Key: 320773418
• Report Number: 9615050-2023-00310
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Public: ++M33530010291318$$+730200367/16D
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 300102913
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2018
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1