MAUDE Adverse Event Report: I-FLOW CORP., LLC HOMEPUMP C-SERIES: 270 ML, 2ML/HR; ELASTOMERIC PUMP

Model Number C270020

Device Problem Infusion or Flow Problem (2964)

Patient Problems Dehydration (1807); Reaction (2414)

Event Date 02/10/2014

Event Type  Injury  

Event Description

Drug/diluent: 5 fu, 2000mg/0.9%nacl 243 ml.Fill volume: 243 ml.Flow rate: 2ml/hr.Procedure: chemotherapy.Cathplace: chest port.A maude report (ref# (b)(4)) was received, describing a (b)(6) old female pt who experienced mucositis, stomatitis, dehydration, malnutrition and was hospitalized while using the homepump.Additional info provided: pt received 5fu via elastomeric pump.Medication infused over 4 days rather than 5 days.No sign of over leakage.On (b)(6), the infusion started and the pt experienced symptoms 4 days after.She also finished radiation treatment for her colon cancer on (b)(6).The pump was reported to be empty on (b)(6).On (b)(6), she was hospitalized from mucositis, stomatitis, dehydration, malnutrition.Pt received treatment including iv fluids and antemetic, symptoms dissipated after treatment and she was discharged on (b)(6).It was reported that the pt's current condition is fine.Date/time infusion start: (b)(6) 2014 at 12:44pm.Date/time infusion stop: (b)(6) 2014 at 11:17am.Date/ time incident/defect noticed: (b)(6) 2014 at 11:17am.Pump was reported to be empty at the time of disconnect.

Manufacturer Narrative

Method: the device was returned for an evaluation and investigation, a visual inspection was performed on the returned unit and testing is currently in progress.A review of the device history record (dhr) is in progress for the reported lot number.Results: at this time, the results are pending the completion of the evaluation and investigation which is currently in progress.Conclusions: the device was received for evaluation and investigation.Testing is currently being performed on the returned unit.A follow-up report will be filed when the investigation has been completed.Information from this incident will be included in our product complaint and mdr trend reporting system.Additional investigation may arise from ongoing analysis, trend information, or other analysis as appropriate.

• Brand Name: HOMEPUMP C-SERIES: 270 ML, 2ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW CORP., LLC; irvine CA 92630
• Manufacturer Contact: maria wagner ; a kimberly-clark health care company; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3784147
• MDR Text Key: 15362454
• Report Number: 2026095-2014-00049
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: C270020
• Device Catalogue Number: 10135660
• Device Lot Number: 0201022130
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/10/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2014
• Initial Date FDA Received: 04/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: HUBER PLUS 20G CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 66