MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS, CLOSED MALE LUER; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number CH2000S

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

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

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

One used list # ch2000s, spinning spiros (lot # unknown) and one used list # unknown, smallbore extension set, spinning spiros, nano y-clave, clear microclave were received and visually inspected.As received, the spin feature of the stand-alone spiros was activated.No spline damage or evidence of a shear tab malfunction was seen.The bd alaris set was not returned.The returned devices were functionally tested and met product performance and measurement expectations outlined in the product performance specification.No manufacturing related damage or anomalies were observed that would lead to a disconnection.The reported complaint of a disconnect can be confirmed.However, the probable cause cannot be determined as no mating device that connects to the female luer of the spiros was returned.The device history review could not be completed since no lot number was provided.Due to a system limitation, the date is inadvertently marked as (b)(6) 2020 for this initial emdr.The correct date is (b)(6) 2020.

Event Description

The event involved a spinning spiros® closed male luer, red cap that disconnected from an unknown alaris tubing, 22 to 23 hours into an infusion of cytarabine and a leak was noted outside the closed system resulting in exposure to the patient, family and staff.The chemo was reported to be stopped mid infusion.There was patient involvement, and although a delay in therapy was reported, there was no adverse event or harm as a result of the reported event.

• Brand Name: SPINNING SPIROS, CLOSED MALE LUER
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 10445247
• MDR Text Key: 205712247
• Report Number: 9617594-2020-00336
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CH2000S
• Device Catalogue Number: CH2000S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1