MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 14687-15

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 02/15/2024

Event Type  malfunction  

Event Description

It was reported that a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch cracked and generated a leak of an unspecified medication during patient use.The reporter stated, "plum set cracked which resulted in drug leakage." there was no drug exposure to the patient or healthcare provider.There was no healthcare provider harm.There was no patient harm reported.

Manufacturer Narrative

Received one (1) used list #14687-15 primary plum set.The set was attached to an icu medical provided intravenous (iv) bag and primed per packaging directions.A leak was noted to be coming from the cassette and no further infusion was attempted.The set was also air pressure leak tested and there were two leaks observed along the edge of the cassette.Additionally, the cassette underwent stack height measurements of which two corners failed.The complaint of plum set cracked which resulted in leakage can be confirmed.The probable cause of this event is related to the product being exposed to excessive heat during transportation, which may contribute to the warpage of the cassette leading to cassette errors and leakage.The lot history was reviewed, and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH
• 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: 18909736
• MDR Text Key: 337766687
• Report Number: 9615050-2024-00235
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)260801(10)13670553
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 14687-15
• Device Lot Number: 13670553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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: UNSPECIFIED FLUID, UNK MFR