MAUDE Adverse Event Report: HALYARD HOMEPUMP C-SERIES 270ML, 5ML/HR; ELASTOMERIC PUMP

Model Number C270050-10

Device Problem Infusion or Flow Problem (2964)

Patient Problems Diarrhea (1811); Fatigue (1849)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

It was reported by a pharmacy in (b)(4) that 7 incidents of fast flow occurred using pumps on 4 different pts.It was reported that 2 of the 7 devices are available for return and analysis.Please reference: 2026095-2015-00006/14-01146 (a), 2026095-2015-00007/14-01146 (b), 2026095-2015-00008/14-01146 (c), 2026095-2015-00008/14-01146 (d), 2026095-2015-00008/14-01146 (e) and 2026095-2015-00011/14-01146 (g).Pt #4 of 4: incident #2 of 3-infusion started (b)(6) 2014 at 1:00pm and ended (b)(6) 2014 at 7:00pm.The infusion ended in 30 hours instead of 44 hours "during 3 consecutive cures of chemotherapy'.Medical consequences were gastrointestinal toxicity with pain, diarrhea and tiredness.One of the devices from pt #4 was saved for return and analysis.Currently, clarification has been requested on the returning device and is not available at this time.Fill volume: 220ml, flow rate: 5ml/hr, procedure: chemotherapy and cathplace: picc.

Manufacturer Narrative

Method: one of the three devices used for pt #4 was reported to be returning for eval.Currently, clarification has been requested on the returning device and is not available at this time.At this time halyard is pending receipt of the device.A review of the device history record (dhr) is in progress for the reported lot number.Results: at this time the investigation is still in progress.Once the device is received, testing will be performed and results will be provided once completed.Conclusions: once the investigation and device analysis are completed, a f/u report will be submitted.

• Brand Name: HOMEPUMP C-SERIES 270ML, 5ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4437656
• MDR Text Key: 5316594
• Report Number: 2026095-2015-00011
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 12/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: C270050-10
• Device Catalogue Number: 103488300
• Device Lot Number: 0201496620
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• 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: FLUOROURACIL 15MG/ML; NACL 0.9%
• Patient Age: 56 YR
• Patient Weight: 54