MAUDE Adverse Event Report: ICU MEDICAL, INC. CHEMOCLAVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number CH-13

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

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

Event Date 03/18/2014

Event Type  malfunction  

Event Description

Iv tubing delivering chemotherapy was noted to have a slow steady leak at site above the drip chamber.A chemo spill kit was obtained.Chemo administration was stopped and the remaining chemo volume was noted per physician note.Iv bag and tubing were taken down, triple bagged, and returned to pharmacy.Iv pump disinfected by environmental health services and a new iv pump obtained.Patient was instructed to wash hands thoroughly.

• Brand Name: CHEMOCLAVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 3775179
• MDR Text Key: 15932818
• Report Number: 3775179
• Device Sequence Number: 1
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/21/2014

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: Invalid Data
• Device Catalogue Number: CH-13
• Device Lot Number: 2798540
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/28/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2014
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 72