MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X100,HM PMP,-,EC,10; ELASTOMERIC HFR

Model Number E401000-10

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Information (3190)

Event Date 12/03/2016

Event Type  malfunction  

Manufacturer Narrative

Method: the actual device was not returned.The device history record for the reported lot number was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the halyard health complaint database and identified as (b)(4).Device not returned.

Event Description

Halyard received a single report that referenced three different incidents, which were associated with separate units, involving a single.This is the third of three reports.Refer to 2026095-2016-00229 for the first patient.Refer to 2026095-2016-00230 for the second patient.Fill volume: 125 ml, flow rate: 100 ml/hr, procedure: unknown, cathplace: not applicable.It was reported that a homepump infused within 1 hour and 30 minutes instead of 4 hours, and occurred with 3 devices in a row.It was noted that patient experienced undesirable effects (unspecified) due to the rapid infusion.

• Brand Name: SURGPN,400X100,HM PMP,-,EC,10
• Type of Device: ELASTOMERIC HFR
• 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: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6215365
• MDR Text Key: 63622079
• Report Number: 2026095-2016-00231
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2017
• Device Model Number: E401000-10
• Device Catalogue Number: 103488802
• Device Lot Number: 0202101729
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1