MAUDE Adverse Event Report: HALYARD - IRVINE HOMEPUMP ECLIPSE I-FLOW 400ML; PUMP, INFUSION, ELASTOMETRIC

Model Number E401000

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/30/2015

Event Type  malfunction  

Event Description

Patient was receiving vancomycin when the infusion began to leak from the tubing.It leaked around the filter.Per the homecare pharmacist, the leak occurred with the air eliminating filters.

• Brand Name: HOMEPUMP ECLIPSE I-FLOW 400ML
• Type of Device: PUMP, INFUSION, ELASTOMETRIC
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery suite 100; irvine CA 92618
• MDR Report Key: 5337808
• MDR Text Key: 34758571
• Report Number: 5337808
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 12/31/2017
• Device Model Number: E401000
• Device Catalogue Number: E401000
• Device Lot Number: 0202209903
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2015
• Device Age: 1 DY
• Event Location: Home
• Date Report to Manufacturer: 12/11/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 5 YR