MAUDE Adverse Event Report: ICU MEDICAL, INC. SPIROS CLOSED SYSTEM TRANSFER DEVICE; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Description

Small volume iv push methotrexate is administered to post bmt patients in a syringe with a spiros cstd (closed system transfer device).The spiros cstd is not used for compounding and is not primed with drug.The prime volume is 0.1 ml.There is concern that a significant portion of the dose is not injected with the use of this cstd.There is 0.1 ml left behind in the dead space of the spiros closed system transfer device.This dead space volume was not appreciated during 1 year of use and resulted in underdosing of methotrexate at our facility.Pump failure/malfunction inappropriate/inaccurate measuring device improperly used (i.E., pump, device) dispensing device involved.Severity: error resulted in initial or prolonged hospitalization; temporary patient harm.(b)(4).

• Brand Name: SPIROS CLOSED SYSTEM TRANSFER DEVICE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.
• MDR Report Key: 12787904
• MDR Text Key: 280819760
• Report Number: MW5105251
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1