MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 14001-31

Device Problem Crack (1135)

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

Event Date 12/23/2023

Event Type  malfunction  

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.

Event Description

It was reported that an equipo bomba set primario plum (set for infusion with infusion pumps), was found to have a split.The report stated that in the intensive care unit-a, the noradrenaline equipment presented damage (rupture during patient infusion).There was a set replacement for a new one.The disposable was not used more than one time.The set was not sent and is not available for evaluation.The event was classified by the reporter as a non-serious adverse event, private nature, complexity level 1.It was reported that the probable cause of the incident was user error, and no corrective actions were taken.There was no patient harm reported.

• Brand Name: PRIMARY PLUM SET, 15 MICRON FILTER IN SIGHT CHAMBER, CLAVE SECONDARY PORT, CLAVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 18919170
• MDR Text Key: 337855566
• Report Number: 9615050-2024-00236
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887709100883
• UDI-Public: (01)10887709100883(17)260801(10)13675513
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14001-31
• Device Lot Number: 13675513
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NORADRENALINE, UKN MFR.
• Patient Age: 65 YR
• Patient Sex: Male