MAUDE Adverse Event Report: I-FLOW, LLC HOMEPUMP ECLIPSE: 400 ML, 100 ML/HR; ELASTOMERIC PUMP

Model Number E401000-10

Device Problem Infusion or Flow Problem (2964)

Patient Problem Anxiety (2328)

Event Date 04/16/2014

Event Type  malfunction  

Event Description

Fill volume: 400 ml, flow rate: 100 ml/hr, procedure: not provided, cathplace: in the arm.It was reported that infusion on a patient completed within 1 hour and 40 minutes instead of 4 hours.(incident as reported) "infusion within 1h40 instead of 4 hours.Consequences the patient suffered: anxiety, no medical intervention required.Patient's current condition: nothing to mention.".

Manufacturer Narrative

Method: the sample has been received by the reporter for inspection and evaluation.A visual examination was performed on the device, and a review of the device history record (dhr) was conducted for the lot number reported.Results: at this time the results are pending the completion of the evaluation and investigation which is currently in progress.Per the dhr review the lot passed all manufacturing specifications prior to release.Conclusions: a conclusion is not yet available as the investigation and evaluation of the device is still in progress.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 ECLIPSE: 400 ML, 100 ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3915187
• MDR Text Key: 16086943
• Report Number: 2026095-2014-00065
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/23/2014

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: Health Professional
• Device Expiration Date: 09/30/2015
• Device Model Number: E401000-10
• Device Catalogue Number: 103488800
• Device Lot Number: 0200983842
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/12/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/23/2014
• Initial Date FDA Received: 05/16/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2013
• 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: DRUG/DILUENT: SOLUMEDROL, NAC1 0.9%
• Patient Age: 39 YR