MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIROS CHEMO TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number (10)23025107

Patient Problem Chemical Exposure (2570)

Event Date 12/19/2021

Event Type  malfunction  

Event Description

Spiros chemo tubing lot# (10)23025107 found with pin hole leak in it's upper soft tubing that goes inside the iv pump.There was only saline in the line at the time of the leak.Tubing removed and the lot was pulled pending further investigation.

• Brand Name: SPIROS CHEMO TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
• MDR Report Key: 18425485
• MDR Text Key: 331835448
• Report Number: MW5149694
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: (10)23025107
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: BD ALARIS PUMP INFUSION SET.
• Patient Outcome(s): Other
• Patient Age: 1 DA
• Patient Sex: Female
• Patient Race: American Indian Or Alaskan Native