MAUDE Adverse Event Report: HALYARD EASYPUMP: LT 270-54: 270ML, 5 ML/HR; ELASTOMERIC PUMP

Model Number 004438043

Device Problem Infusion or Flow Problem (2964)

Patient Problem Weakness (2145)

Event Date 09/18/2014

Event Type  malfunction  

Event Description

Fill volume: 244 ml.Flow rate: 5 ml/hr.Procedure: port access installation.Cathplace: external jugular port (smiths gripper).It was reported that the easypump was expected to infuse in 46 hours, but instead infused in 30 hours.Following the infusion, the patient experienced weakness and low immunity.No medical intervention was given.It was reported that the patient's current condition is stable.Infusion start: (b)(4) 2014 at 05:30 pm.Infusion end: (b)(4) 2014 at 11:00 pm.

Manufacturer Narrative

Method: the evaluation of the device is not available as the device was reported as unavailable for return and analysis.Reviews of the device history record (dhr) and instructions for use (ifu) were conducted for the reported model and lot number.Results: the device history record (dhr) was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related non conformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusions: limited information was provided by the reporter; therefore further information has been requested, but has not yet been provided.The device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.If additional information pertinent to this event becomes available, halyard will send a follow-up report.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: EASYPUMP: LT 270-54: 270ML, 5 ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4260712
• MDR Text Key: 5029567
• Report Number: 2026095-2014-00242
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 10/20/2014

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: 01/31/2016
• Device Model Number: 004438043
• Device Catalogue Number: 101359500
• Device Lot Number: 0201098979
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2014
• Initial Date FDA Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SALINE 0.9%