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

Model Number E401000

Device Problem Infusion or Flow Problem (2964)

Patient Problems High Blood Pressure/ Hypertension (1908); Palpitations (2467)

Event Type  malfunction  

Event Description

Fill volume: unknown.Flow rate: 100 ml/hr.Procedure: unknown - anp.Cathplace: unknown.Patient 2 of 3.Please reference 2026095-2014-00117/14-00495 (a), 2026095-2014-00119/14-00495 (c).It was reported that three patients experienced fast flows while using a e401000 pump.The nurse did not wait the 4 hours between filling the pump and infusion.Patient two's pump infused solu-medrol in 2.5 hours instead of the expected 4 hours.Anp: asked not provided.

Manufacturer Narrative

Method: at this time only one device has been received for an analysis.We are currently pending the return of this device.A review of the device history records (dhr) was performed for the lot number provided.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 lot.The lot met the process specifications at release.Conclusions: i-flow is awaiting the return of the two additional devices that were reported to be available for analysis.The investigation is ongoing, once 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 CORP.; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, sute 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3999058
• MDR Text Key: 4775877
• Report Number: 2026095-2014-00118
• 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,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2015
• Device Model Number: E401000
• Device Catalogue Number: 103488800
• Device Lot Number: 0200974832
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/01/2013
• 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: SOLU-MEDROL LG DILUTED IN 400ML OF G5%