MAUDE Adverse Event Report: ICU MEDICAL, INC. SPIROS; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 5239751

Device Problems Disconnection (1171); Reflux within Device (1522)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2021

Event Type  malfunction  

Event Description

Parent rang bell and stated that the patients tubing had become disconnected.This rn immediately paused the infusions and asked for other rn's assistance since chemo was involved.Methotrexate and iv fluids were infusing into the patient when the disconnect happened.The spiros cap connecting the fluid line to the patient became disconnected from the patient.No chemo was spilled, however the patient started backing the tubing up with blood.Rn's then obtained another fluid bag with new tubing and restarted the infusion.

• Brand Name: SPIROS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 12466631
• MDR Text Key: 271285079
• Report Number: 12466631
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 5239751
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 870 DA