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

Model Number CH2000S-C

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problems Underdose (2542); Blood Loss (2597)

Event Date 10/14/2019

Event Type  malfunction  

Event Description

Rn notified by patient that iv was leaking.Tubing became disconnected from spinning spiros cap at distal end near patient.Chemotherapy infusing through huber needle in port.Blood backed up through port and out tubing.New iv tubing with spiros cap initiated to resume infusion.Patient notified rn approx.1.5 hours later that the tubing had come disconnected for a second time.

• Brand Name: SPINNING SPIROS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC; 4455 atherton dr; salt lake city UT 84123
• MDR Report Key: 9503961
• MDR Text Key: 172240790
• Report Number: 9503961
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2019,10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CH2000S-C
• Device Catalogue Number: CH2000S-C
• Device Lot Number: 4191348
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2019
• Date Report to Manufacturer: 12/20/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA