MAUDE Adverse Event Report: HALYARD - IRVINE HOMEPUMP C-SERIES: 270 ML, 10 ML/HR; ELASTOMERIC PUMP

Model Number C270100

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 (ncr's) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusion: the device was not returned for evaluation, therefore we are unable to determine the cause for the reported event.It was reported that the pump was underfilled to 240ml and not placed under a blanket.However, no additional information could be obtained and a root cause could not be determined.Per the instructions for use (ifu) 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.Should additional information pertinent to this event become available, halyard will submit a follow-up report.Information from this incident has been included in our product complaint reporting systems for monitoring, tracking and trending purposes.Device not returned for evaluation.

Event Description

(b)(6).Please reference: 2026095-2015-00363/(b)(6).Incident #2 of 2: it was reported on (b)(6) 2015 by the distributor that a patient had two pumps under filled with 240 ml penicillin and they infused at 15-16 hours instead of 24 hours, or faster than expected.Pharmacist reported that the pumps were filled per syringe, with no air bubbles and there were never frozen, clamps were closed after filling and stored at room temperature.It was reported that the pumps were attached by a family member and placed on the outside of the blanket and rate was not changed.No patient injury or complication was reported.

Manufacturer Narrative

Corrected the aware date to (b)(6) 2015 from (b)(6) 2015.

• Brand Name: HOMEPUMP C-SERIES: 270 ML, 10 ML/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-18; fraccionamiento rubio; tijuana, b.c.
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5335783
• MDR Text Key: 35256080
• Report Number: 2026095-2015-00364
• 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: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2015

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: Pharmacist
• Device Expiration Date: 11/30/2017
• Device Model Number: C270100
• Device Catalogue Number: 101356902
• Device Lot Number: 0202177860
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2015
• 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 Age: 93 YR