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

Model Number E401000-10

Device Problem Infusion or Flow Problem (2964)

Patient Problems Low Blood Pressure/ Hypotension (1914); Weakness (2145)

Event Date 07/15/2014

Event Type  malfunction  

Event Description

Fill volume: 400 ml.Flow rate: 100ml/hr.Procedure: therapy cathplace: peripheral iv in arm.It was reported that a female patient experienced a fast flow while using a pump.The incident occurred (b)(6) 2014 and it was initially reported that "infusion of the corticoids infused within 2 hours instead of 4 hours." additional information was received that the infusion was started on (b)(6) 2014 at 08:00 via a peripheral iv and completed on the same day at 11:00.This incident was noticed by the patient and the pump was reported to be empty at the end of the infusion.The patient was reported to have hypotension and asthenia.No medical intervention required.

Manufacturer Narrative

Method: the device was reported not to be returning for analysis.A review of the device history record (dhr) was conducted for the lot number reported, along with a review of the instructions for use (ifu).Results: the device met all specifications at release.As a device was not available for an evaluation, no methods were performed; therefore, results cannot be obtained.Conclusion: a device evaluation could not be conducted as the device was reported to not be returning.Based on the reported incident information the device was filled and infusion was started on (b)(6) 2014 at 08:00 and completed on the same day at 11:00am.According with the information reported, the user did not wait the four hours as required by the instruction for use.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.

• Brand Name: HOMEPUMP ECLIPSE 400ML, 100ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW CORP.; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4102692
• MDR Text Key: 4718930
• Report Number: 2026095-2014-00157
• 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: Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/31/2014

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 Expiration Date: 09/30/2015
• Device Model Number: E401000-10
• Device Catalogue Number: 103488800
• Device Lot Number: 0200983842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2014
• Initial Date FDA Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 1G OF SOLUMEDROL IN GLUCOSE 0,5%,; 30MM/20G KELIS MED CATHETER.
• Patient Age: 37 YR