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

Model Number E401000-10

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Headache (1880)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is in-progress.Upon completion of the investigation; a follow-up report will be filed.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.(b)(4).

Event Description

Halyard received a single report that referenced two different incidences, which were associated with separate units, involving a single patient.This is the second of two reports.Refer to 2026095-2017-00003 for the first event.Fill volume: 500 ml, flow rate: 100 ml/hr, cathplace: iv.It was reported that the infusion occurred in 2.5 hours to 3 hours on the first day and then 3 hours to 3.5 hours on the second day.The pump should have lasted for 5 hours.It was noted that good usage practices were observed by an independent nurse and the patient.It was also noted that the patient experienced headaches.

Manufacturer Narrative

The device history record of the reported lot was reviewed.According with the results the production lot met all manufacturing and quality specifications.All information reasonably known as of 10-apr-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.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 complaint (b)(4).

• Brand Name: SURGPN,400X100,HM PMP,-,EC,10
• Type of Device: NON-DEHP PUMP - 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6236406
• MDR Text Key: 64268742
• Report Number: 2026095-2017-00004
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2017

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: Other
• Device Expiration Date: 08/31/2017
• Device Model Number: E401000-10
• Device Catalogue Number: 103488802
• Device Lot Number: 0202120116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SOLUMÉDROL 1 G IN 500 ML OF 0.09% NACL