MAUDE Adverse Event Report: HALYARD EASYPUMP ST 400 - 4:400ML, 100ML/HR; ELASTOMERIC PUMP

Model Number 4434360

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2014

Event Type  malfunction  

Event Description

Fill volume: 350ml.Flow rate: 100ml/hr.Procedure: unk.Cathplace: unk.Please reference: 2026095-2014-00293/(b)(4).Device 1 of 2: an international distributor reported that 2 incidents of fast flow occurred.It was reported as, "the flow rate was too fast".It was reported that the pumps were used directly after filling.No patient injury or medical intervention was reported.The device is available for return and analysis.Additional information was requested but is not available at this time.Infusion start time: (b)(6) 2014 at 09:30am.Infusion end time: (b)(6) 2014 at 11:10 am.

Manufacturer Narrative

Method: a partially full device was received for analysis.At this time, clarification on the device is being requested from the reporter.In addition, a review of the device history record (dhr) was performed.Results: there are no testing results available as the investigation and evaluation are currently in progress.Conclusions: once the analysis and investigation are completed a follow-up report will be submitted.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 ST 400 - 4:400ML, 100ML/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: 4381551
• MDR Text Key: 5120288
• Report Number: 2026095-2014-00292
• 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: Not Applicable
• Type of Report: Initial
• Report Date: 12/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 4434360
• Device Catalogue Number: 101373100
• Device Lot Number: 0201232600
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• 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: SOLUMEDROL 1 GRAM; CATHETER: KT VVP + CONNECTOR CLAMP