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

Model Number 1468728

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/28/2021

Event Type  Death  

Event Description

The event involved a primary plumset that the customer stated the tubing connection broke into the blue y-site connection causing a leak of vasopressors.The customer reported they believe the vasopressor did not infuse after the connection.At approximately 1830 the patient was four vasopressors that were all y-sited to the medial line on the central venous catheter (cvc).The epinephrine was quad concentrated and last in the y-site.The patient¿s blood pressure was not responding to the epinephrine, so the customer thought the infusion was not at a high enough rate.They reported they disconnected the epinephrine and attached it to the proximal lumen of the cvc.The blood pressure was not responding to the epinephrine and the line flushed at the y-site which was noted to be leaking at the tubing connection to cap.The leaking also noted to previous y-site connections and blood backing up into the cvc line.The vasopressor bags were re-spiked and tubing was rehung.Additionally, it was noted the end of the epinephrine tubing was broken and the piece was stuck in the previous y-site.The patient continued to be hypotensive despite maximum on vasopressor.At 1837 the patient was eventually asystole, reported to be a limited code, family stated not to push code medications.There was patient involvement, there was an adverse event, and a delay in therapy.Multiple requests for additional information has been made.No additional information has been received at this time.Investigation received one used list #146870489, primary plum set, clave secondary port, clave y-site, secure lock, 103 inch; lot #5409747 and one used list #306547, bd posiflush 0.9% sodium chloride injection, usp single use 10 ml syringe; lot #1228508.The sample had the tip of the distal male luer broken off.The shape of the deformation was similar to the first sample where one portion is angled higher than the other side.The lower portion had the beach mark deformation and the higher portion was smooth which corresponds to the deformation observed on the male luer tip found in the y-clave of the first sample.There were no other damages or anomalies noted.The probable cause of the broken male luer tip inside the y-clave is due to an unintentional bending force during use.

• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13427699
• MDR Text Key: 284914296
• Report Number: 9615050-2022-00015
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)240601(10)5409747
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1468728
• Device Catalogue Number: 146870489
• Device Lot Number: 5409747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2021
• 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: CENTRAL VENOUS CATHETER, MFR UNK; EPINEPHRINE, MFR UNK; UNSPECIFIED VASOPRESSORS, MFR UNK
• Patient Outcome(s): Death