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 Problems High Blood Pressure/ Hypertension (1908); Swelling (2091); Tachycardia (2095)

Event Date 07/26/2014

Event Type  malfunction  

Event Description

Report 1 of 2.It was reported that a fast flow occurred with two homepumps.It was reported that a pump was filled on (b)(6) 2014 at 10:00 by the nurse at the patient's home.At 10:10 on the same day, the infusion began.On (b)(6) 2014 at 12:10, the infusion ended (pump was empty).The pump infused within 2 hours instead of 3 hours.Following the infusion, the patient experienced tachycardia, and elevated blood pressure (16).No medical intervention was given.Currently, the patient is reported to be okay, but has facial edema due to cortisone.

Manufacturer Narrative

Method: the device was received for analysis.A visual inspection was performed and a review of the device history record was conducted for the lot number.Results: at this time, the evaluation is still in progress.Results will be provided once completed.Per the dhr review, there were no reworks, special conditions, or related nonconformance reports (ncrs) for this reported lot number.The lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusions: once the investigation and device analysis are completed, a follow-up report will be submitted.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: 4102301
• MDR Text Key: 4757713
• Report Number: 2026095-2014-00154
• 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: 07/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Model Number: E401000-10
• Device Catalogue Number: 103488800
• Device Lot Number: 0201089458
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/26/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2013
• 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: NON-I-FLOW CATHETER (BRAND UNK); DRUG/DILUENT: SOLUMEDROL CORTISONE/NAC1 0.9%
• Patient Age: 43 YR