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 14007-31

Device Problem Infusion or Flow Problem (2964)

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

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation.Without the return of the device a comprehensive evaluation cannot be conducted and probable cause cannot be determined.

Event Description

The event involved a primary plum set, 15 micron filter in sight chamber, clave secondary port, clave y-site, polyethylene lined light resistant tubing, distal microbore tubing, secure lock, 272 cm.The customer stated that they were unsure if the port was already depressed or if it was after the secondary line had been attached, but it was causing the pump to alarm.Initially the nurses thought it was the secondary set, however after changing it the same thing happened.Customer further reported that after taking down the secondary line it was noticed that the port was pressed and had not returned to its normal position.The medication involved is paclitaxel.There was no unprotected chemo exposure nor come into contact with the patient or health care provider.No chemo spill; cleaned up per facility protocol and the spill kit was not used.No holes, cuts or defects were noted on the medical device.There was a patient involvement but harm was not reported as a consequence of this event.

• 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: 19165783
• MDR Text Key: 341675226
• Report Number: 9615050-2024-00320
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 14007-31
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: PACLITAXEL, MFR UNK