MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ADMIN SET, AMBER, SPIROS¿; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Catalog Number 011-CH3751

Device Problem Particulates (1451)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

The device was discarded.Without the returned device a probable cause can not be established.

Event Description

The event involved 76 cm (30") amber 20 drop admin set w/15 micron filter, clamp, 0.2 micron filter, spiros¿ w/red cap that the customer reported during a paclitaxel infusion the filter broke off in the drip chamber and left debris leading to constant alarming of the pump.The filter was found floating in the chamber and the chemo inside had gone cloudy in color.The patient was not able to get the remaining 60 ml left in the bag.The chemo was removed and discarded with the line.There was patient involvement, however no report of harm or adverse event.

Manufacturer Narrative

H10: no product samples were returned for investigation, however, two photographs were returned showing a drip chamber with a side port filter cap open.The size and resolution of the photos were small and low thus preventing confirmation of debris in the drip chamber.No device history review (dhr) lot review was conducted because no lot number(s) was/were identified.A probable cause cannot be identified based on the information that has been provided.

• Brand Name: ADMIN SET, AMBER, SPIROS¿
• 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. ; MX
• MDR Report Key: 9559090
• MDR Text Key: 187701525
• Report Number: 9617594-2020-00003
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K173477
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2019

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: 011-CH3751
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PACLITAXEL, UNK MFR; UNSPECIFIED PUMP