MAUDE Adverse Event Report: HALYARD - IRVINE HOMEPUMP C-SERIES 60ML, 2ML/HR; ELASTOMERIC PUMP

Model Number C060020-10

Device Problem Infusion or Flow Problem (2964)

Patient Problem Inflammation (1932)

Event Date 05/22/2015

Event Type  malfunction  

Manufacturer Narrative

Method: the device was reported as not available for return and analysis.The lot number was received and a review of the device history record (dhr) was conducted for the lot number reported.Results: as the device was not available for analysis, no device testing methods were performed.For this reason results cannot be obtained.However, the dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.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.¿ filling the pump less than labeled (nominal) fill volume results in faster flow rate." 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 by the reporter.Attempts were made to obtain additional information without success.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

Please reference: 2026095-2015-00186/15-00574(b).Fill volume: 30ml.Flow rate: 2ml/hr.Procedure: desferal therapy.Cathplace: asku.Incident #1 of 2: it was reported that a customer in (b)(6) experienced two incidents of a pump's infusion ending sooner than expected.It was reported that usually the nurses fill the pumps in the evening to 30ml and that the pumps infuse within 12 hours.It was further reported as, "since last delivery , the new homepumps used the same way are getting empty within +/- 6 hours, twice the scheduled/foreseen flow." the patient reported the presence of a nodule at the injection points and that the patient did not have this problem before.The device is not available for return.

• Brand Name: HOMEPUMP C-SERIES 60ML, 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. 2211 6; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4889361
• MDR Text Key: 16608529
• Report Number: 2026095-2015-00185
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2015

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: Lay User/Patient
• Device Expiration Date: 02/28/2017
• Device Model Number: C060020-10
• Device Catalogue Number: 103489200
• Device Lot Number: 201565162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2014
• 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: DESFERAL