MAUDE Adverse Event Report: ICU MEDICAL INC SPINNING SPIROS CLOSED MALE LUER, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Model Number CH2000S-C

Device Problems Inadequate Instructions for Healthcare Professional (1319); Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem Insufficient Information (4580)

Event Date 11/21/2020

Event Type  malfunction  

Event Description

Busulfan was wasted and had to be remade due to leak on the unit.Nurse asked pharmacy to remake medication due to leak.I called nurse to clarify details.Sounds like after priming on the unit, medication was found to be leaking from the spiros (icumedical spinning spiros closed male luer, red cap, lot 4991021).Pharmacy remade and sent new bag to unit with a different spiros lot number.Upon further investigation after speaking to nurse, its sounds like nurse did not put on a c clip while priming, which led to leak out of spiros.Nurse said that she was told it was optional to have c clip.Not sure if there was previous communication regarding not needing c clip, but there needs to be further nursing education now regarding circle priming and c clips.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER, RED CAP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL INC; 600 n field dr; lake forest IL 60045
• MDR Report Key: 10939848
• MDR Text Key: 219331251
• Report Number: 10939848
• 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: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CH2000S-C
• Device Lot Number: 4991021
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17155 DA