MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIROS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570); Blood Loss (2597)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.It has not been received.

Event Description

The event involved a spiros that the customer reported the spiros cap disconnected from the iv tubing, microclave, or syringe.The back of the spiros disconnected from the luer lock of a bifuse or a trifuse.The disconnection occurred during administration of cytarabine, and the duration of the infusion was more than 2 hours.There was a report of loss of blood due to the patient line being opened.The environment, the patient, the parent, and the staff member were exposed to the hazardous drug due to the spill.There was patient involvement, but no report of harm.

Manufacturer Narrative

H10: no product samples, videos, or photographs were returned for investigation.A device history review (dhr) lot review could not be conducted because no lot number(s) was/were identified.A probable cause cannot be identified based on the information that has been provided.Additional information in section d10.

• Brand Name: SPIROS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. ; MX
• MDR Report Key: 10862368
• MDR Text Key: 217676125
• Report Number: 9615050-2020-00251
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

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 Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/18/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BIFUSE, MFR UNK.; CYTARABINE, UNK MFR.; TRIFUSE, MFR UNK.