MAUDE Adverse Event Report: HALYARD EASYPUMP LT 270-132: 270 ML, 2 ML/HR

Model Number 04434376

Device Problem Infusion or Flow Problem (2964)

Patient Problem Ulcer (2274)

Event Date 01/21/2015

Event Type  malfunction  

Event Description

Fill volume: 325 ml.Flow rate: 2 ml/hr.Procedure: chemotherapy.Cathplace: chest (left upper thorax).Infusion started on (b)(6) 2015.Infusion ended on (b)(6) 2015.An international distributor reported that an infusion ended sooner than expected.It was reported as "the drug finished early.The pump was prepared for 7 days, but finished in 4.5 days." following the event, the pt experienced mild oral apthae that required unspecified oral care.The pt is currently doing well.

Manufacturer Narrative

The device was received for analysis.A visual inspection was performed and a review of the device history record (dhr) was performed.There are no device testing results available as the investigation and eval are currently in progress; however, the dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformity reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.Once the analysis and investigation are completed a follow up report will be submitted.Info from this incident has been included in our product complaint and mdr trend reporting systems.Trend info is used to identify the need for additional investigations.

• Brand Name: EASYPUMP LT 270-132: 270 ML, 2 ML/HR
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4574722
• MDR Text Key: 22055433
• Report Number: 2026095-2015-00088
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: 04434376
• Device Catalogue Number: 101359200
• Device Lot Number: 0200995909
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/24/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2015
• Initial Date FDA Received: 03/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2013
• 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: 46.5 ML 5-FU; 278 ML SALINE
• Patient Outcome(s): Required Intervention