MAUDE Adverse Event Report: HALYARD HOMEPUMP C-SERIES: 100ML, 2ML/HR; ELASTOMERIC PUMP

Model Number C100020-10

Device Problem Infusion or Flow Problem (2964)

Patient Problems Muscle Weakness (1967); Skin Discoloration (2074); Vomiting (2144)

Event Date 12/07/2014

Event Type  malfunction  

Event Description

Fill volume: unk.Flow rate: 2ml/hr.Procedure: chemotherapy.Cathplace: port-a-cath (chest).Infusion began on (b)(6) 2014 at 1800.Infusion ended on (b)(6) 2014 at 0600.It was reported that an infusion finished within 12 hours instead of the expected 48 hours.The incident was noted 2 hours after the infusion ended.Clinical consequences noted were asthenia, vomiting, nausea, loss of appetite, sparse epistaxis and coloration of fingertips.The device is reported at a later time that the patient's clinical status returned to the same status as noted prior to the incident.Additional information was requested, but is not available at this time.

Manufacturer Narrative

Method: the device was reported to be returning for an evaluation and at this time is pending return.A review of the device history record (dhr) was conducted for the reported lot number.Results: at this time, the investigation is still ongoing.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 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: HOMEPUMP C-SERIES: 100ML, 2ML/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: 4381574
• MDR Text Key: 5120291
• Report Number: 2026095-2014-00291
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: C100020-10
• Device Catalogue Number: 103489400
• Device Lot Number: 0201146313
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 12/31/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2013
• 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: FLUOROURACIL; DRUG: DEXTROSE; PORT-A-CATH; HUBER NEEDLE (SMITHS MEDICAL)