MAUDE Adverse Event Report: ICU MEDICAL INC. CHEMOLOCK BAG SPIKE WITH ADDITIVE PORT; CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM

Model Number CL - 13

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2019

Event Type  malfunction  

Event Description

Compounded sterile product was prepared in ns 100 ml partial fill in 150 ml pab container manufactured by b.Braun medical inc.This was intended to be administered to pt through appx 1.5 ml, chemolock bag spike with additive port manufactured by icu medical inc.Event occurred while final product was being administered to pt and the bag spike fell out of the bag resulting in medication spill.Bag spike was found to be loosely attached to b.Braun bag.Add'l spills have occurred using b.Braun bags and icu medical chemolock bag spikes in the past.The spike fits tightly into other bag ports and the problem is isolated to the 150 ml pab container.Fda safety report id(s)# (b)(4).

• Brand Name: CHEMOLOCK BAG SPIKE WITH ADDITIVE PORT
• Type of Device: CLOSED ANTINEOPLASTIC AND HAZARDOUS DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Manufacturer (Section D): ICU MEDICAL INC. ; san clemente CA 92673
• MDR Report Key: 8748719
• MDR Text Key: 149788802
• Report Number: MW5087700
• Device Sequence Number: 2
• Product Code: ONB
• UDI-Device Identifier: 00887709056985
• UDI-Public: 00887709056985
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/26/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: CL - 13
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 86