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

Model Number E401000-10

Device Problem Infusion or Flow Problem (2964)

Patient Problems Tachycardia (2095); Distress (2329); No Code Available (3191)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint product was not returned for evaluation.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.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 three different incidents, which were associated with separate devices, involving the same patient.This is the first of three reports.Refer to 2026095-2016-00176 for the second report.Refer to 2026095-2016-00177 for the third report.Fill volume: 400 ml, cathplace: n/a.It was reported that a patient experienced three issues in three days with three different devices that infused solumedrol.The first day, the patient was being infused with 400 ml, which completed within two hours.On the second day, the patient was infused within three hours and 15 minutes.On the third day, the patient was infused with 500 ml within four hours.The environment and conditions were similar.The devices were discarded.The patient experienced tachycardia, a metallic taste in the mouth, and anguish.

• 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. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6044846
• MDR Text Key: 58414489
• Report Number: 2026095-2016-00170
• 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: distributor,foreign,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2016

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: 08/31/2017
• Device Model Number: E401000-10
• Device Catalogue Number: 103488802
• Device Lot Number: 0202120131
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: SOLUMÉDROL