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

Model Number CH2000S-C

Device Problems Backflow (1064); Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/25/2023

Event Type  malfunction  

Event Description

It seems that once the spinning function is engaged by twisting on the iv tubing, the part of the iv tubing that twists on no longer stays attached to the spiros.This ultimately makes it easy for the iv tubing to detach from the spiros because it then acts more like a slip-tip than a luer lock.And unfortunately, since the tubing detached from the spiros and the spiros was still attached to the microclave closest to the patient, the line remained open, allowing for the backflow of blood out of the patient.Part# ch2000s-c, lot# 13490092.The separation occurred between the primary set line and spiros.Chemo was infusing the day before the incident.After the patient was just infusing continuous fluids.The blood loss was estimated at 30mls.The event resulted in a decrease of hemoglobin level.The set up was a new primary line connected to a single lumen port with ns infusing continuously.We are returning the product to the manufacture.

• Brand Name: SPINNING SPIROS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 17097107
• MDR Text Key: 316858018
• Report Number: 17097107
• 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: 06/08/2023,06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH2000S-C
• Device Catalogue Number: CH2000S-C
• Device Lot Number: 13490092
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other