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 Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2022

Event Type  malfunction  

Manufacturer Narrative

One used list#: 146870489 primary plum set was received for evaluation.A cut was observed in the tubing.The set was tested per product specifications.There was a leak from the cut in the tubing.The manufacturing process was reviewed and there are no sharp objects or instruments on the manufacturing floor capable of the observed damage as a preventative measure.The set was tested per product specifications and a leak was observed from the cut tubing.The probable cause of the cut tubing is a sharp object.How, when, or where the cut happened cannot be determined, however, it would have occurred outside of icu medical possession.Lot history review was performed and no nonconformities were identified that may have contributed to the reported complaint.

Event Description

The event involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch which was reported to have holes found in the tubing while levophed was infusing in the icu during patient use.The hole was observed at a location close to patient connection.There was a drop in the patient¿s blood pressure (into the 40¿s); the tubing was changed and the patient stabilized.The patient required titration of the levophed up for some period afterwards, until the blood pressure recovered.

• 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: 16063006
• MDR Text Key: 308466964
• Report Number: 9615050-2022-00335
• Device Sequence Number: 1
• Product Code: FPA
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1468728
• Device Catalogue Number: 146870489
• Device Lot Number: 5849942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2022
• 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: LEVOPHED, MFR UNK