MAUDE Adverse Event Report: I-FLOW CORP HOMEPUMP ECLIPSE (C-SERIES 100ML, 2ML/HR)

Model Number C100020

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

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

Event Date 01/10/2014

Event Type  No Answer Provided  

Event Description

Patient reported leaking near filter on tubing of i flow homepump eclipse.Patient receiving iv 5fu at home.Chemotherapy spill contained and dose replaced.The rn unclamped tubing and leak occurred 15-30 minutes later.Leaking of chemotherapeutic agent (non-vesicant).

• Brand Name: HOMEPUMP ECLIPSE (C-SERIES 100ML, 2ML/HR)
• Type of Device: HOMEPUMP ECLIPSE (C-SERIES 100ML, 2ML/HR)
• Manufacturer (Section D): I-FLOW CORP
• MDR Report Key: 3596820
• MDR Text Key: 4093116
• Report Number: MW5033968
• Device Sequence Number: 1
• Product Code: MEB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2014

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: Lay User/Patient
• Device Model Number: C100020
• Device Lot Number: 0200946820
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/21/2014
• Patient Sequence Number: 1
• Treatment: LOSARTAN 50MG PO QD; REGLAN 5MG PO PRN; VITAMIN D; METOPROLOL 50MG QD; 5 FU 4200MG IV Q 2 WEEKS; PROTONIX 40MG PD BID; CRESTOR 5MG PO QD
• Patient Age: 71 YR
• Patient Weight: 94