MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE; SET, ADMINSTRATION, INTRAVASCULAR

Catalog Number 123390488

Device Problem Infusion or Flow Problem (2964)

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

Event Date 03/15/2024

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation but has not yet been returned.

Event Description

The event involved a primary plum set, orange polyethylene lined light resistant tubing, clave y-site where the customer stated that the pump showed failure, solution could not drip.The event was noted during infusion and the solution involved was normal saline.There was no other physical damage noted.The set was replaced, and therapy resumed.There was patient involvement, but no patient harm in the event.No other information is available.

Manufacturer Narrative

On (b)(6) 2024 one used list #123390488 primary plum set attached to a bag spike adapter with spiros was received for evaluation.No damage or on anomalies noted.The set was attached to an icu medical provided iv bag, primed per packaging directions, and a test infusion of 10 ml at 400 ml/hr was infused per procedure.No cassette errors, occlusion alarms, or air in line alarms were generated and no restrictions in flow were noted.A picture was returned showing a primary plum set inside a plastic bag.The complaint of pump showed failure and solution could not drip could not be replicated or confirmed.A lot history review could not be conducted because no lot number(s) was/were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, ORANGE POLYETHYLENE LINED LIGHT RESISTANT TUBING, CLAVE Y-SITE
• Type of Device: SET, ADMINSTRATION, 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: 19119313
• MDR Text Key: 340909428
• Report Number: 9615050-2024-00308
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 123390488
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• 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: NORMAL SALINE, MFR UNK.