MAUDE Adverse Event Report: I-FLOW, LLC 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); Muscle Weakness (1967)

Event Date 07/11/2014

Event Type  malfunction  

Manufacturer Narrative

Method: the device was reported not to be returning for an analysis.Results: per the dhr there were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot 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 8:00am.A technical bulletin will be sent to the customer along with the closure letter.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.

Event Description

Fill volume: 400 ml; flow rate: 100 ml/hr; procedure: iv therapy; cathplace: iv.A foreign distributor reported an incident of fast flow that occurred with a homepump.It was reported that the infusion completed in 3 hours instead of the expected 4 hours.The pump was filled, and infusion was reported to have ended at 11:00am the same day.It was reported that the pump was empty at the time of disconnect, and that the patient experienced hypotension and asthenia, but no medical intervention was required as a result of the incident.

• Brand Name: HOMEPUMP ECLIPSE 400ML, 100ML/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: 4041149
• MDR Text Key: 21157592
• Report Number: 2026095-2014-00144
• 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,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/22/2014

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?: Yes
• Initial Date Manufacturer Received: 07/22/2014
• Initial Date FDA Received: 08/19/2014
• 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 DE SOLUMEDROL DAN 400ML 5% GLUCOSE,; KELIS MEDICAL CATHETER BD INSITE 20G, 30MM
• Patient Age: 37 YR