MAUDE Adverse Event Report: HALYARD - IRVINE HOMEPUMP C-SERIES 270ML, 2ML/HR; ELASTOMERIC PUMP

Model Number C270020-10

Device Problem Infusion or Flow Problem (2964)

Patient Problems Erosion (1750); Muscle Weakness (1967); Nausea (1970)

Event Date 07/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the device was reported as not available for return and analysis.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: as the device and lot number were unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Per the instructions for use (ifu) specifies the following: there are several factors that may affect the flow rate including fill volume, temperature, viscosity of the drug solution, pump position, storage time and external pressure."delivery accuracy: when filled to labeled (nominal) volume, homepump c-series* flow rate accuracy is ±15% of the labeled (nominal) flow rate when infusion is started 0-8 hours after fill and delivering normal saline as the diluent at 31°c/88°f with the pump positioned 40 cm (16 inches) below the catheter site.Medications or fluids must be administered per instructions provided by the drug manufacturer.Physician is responsible for prescribing drug based on each patient¿s clinical status (such as age, body weight, disease state of patient, concomitant medication, etc.)." conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.Limited information was provided regarding the patient's use of the device.Multiple attempts were made to obtain additional information without success.If additional information pertinent to this event becomes available, halyard will send a follow-up report.A homepump c-series patient guidelines and technical bulletins (factors affecting flow rate, filling and priming) were sent to the customer.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.

Event Description

Fill volume: 211ml.Flow rate: 2ml/hr.Procedure: chemotherapy.Cathplace: iv central line.Please reference: 2026095-2015-00214/(b)(6) and 2026095-2015-00215/(b)(6).It was reported that there were three patients that experienced incidences of infusions ending sooner than expected while using their pumps.Patient #1 of 3: the patient's infusion finished a day sooner than expected.The infusion was expected to last 96 hours.The patient experienced mucositis and more nausea than normal.The pump was connected to the patient at the clinic on (b)(6) 2015 at 1530.The patient was scheduled to return to the clinic on (b)(6) 2015 for disconnection.However, on (b)(6) 2015, the patient had a home health visit around 1230.The nurse noted that the infusion was finished and disconnected the pump.When the patient returned to the clinic on (b)(6) 2015 for routine lab work, the patient did not exhibit any immediate adverse signs and symptoms.The pump was reported as discarded and unavailable for return.Additional information was received on 08/06/2015.A nurse reported that the patient went to the emergency department via an ambulance, due to weakness from almost zero intake over the previous few days.The patient's family member reported that the patient's mouth was too sore to swallow due to mucositis.Additional information was received on 08/07/2015.The patient was admitted to the hospital on (b)(6) 2015.As of (b)(6) 2015, the patient is still in the hospital.The infusion started on (b)(6) 2015.This was the patient's first dose of chemotherapy for esophageal cancer.Additional information was received on (b)(6) 2015.As of (b)(6) 2015, the patient is still in the hospital.

• Brand Name: HOMEPUMP C-SERIES 270ML, 2ML/HR
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, b.c. 22116 ; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5033586
• MDR Text Key: 24193369
• Report Number: 2026095-2015-00216
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Report Date: 07/31/2015

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 Model Number: C270020-10
• Device Catalogue Number: 103488200
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Weight: 106