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

Model Number C270050-10

Device Problem Infusion or Flow Problem (2964)

Patient Problem Diarrhea (1811)

Event Date 12/05/2014

Event Type  malfunction  

Event Description

It was reported by a pharmacy in france 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: (b)(4).Pt #1 of 4: infusion started (b)(4) 2014 at 12:00pm.The infusion stopped on (b)(4) 2014 at 6:00pm.The infusion ended in 30-35 hours instead of 44 hours.The medical consequence was diarrhea.The device was not saved for return and analysis.Fill volume: 220ml, flow rate: 5ml/hr, procedure: chemotherapy and cathplace: picc.

Manufacturer Narrative

Method: although the device in connection with the reported incident was not saved for return, it was reported that 2 of the 7 devices in connection with the described incidents will be returning for an eval.At this time halyard is pending receipt of the devices.A device with the same lot number 0201496620 may be returning for eval.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 devices are 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; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4437682
• MDR Text Key: 17276542
• Report Number: 2026095-2015-00006
• 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: 53 YR
• Patient Weight: 57