MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X100,HM PMP,-,EC,24; ELASTOMERIC HFR

Model Number E401000

Device Problem Infusion or Flow Problem (2964)

Patient Problems Headache (1880); Weakness (2145)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Udi # unknown.The sample is reported to be available for this complaint but was not returned at the time this report was submitted.The device history record for the reported lot number, 0201402443, was reviewed and documented that the lot was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.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.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 the same patient.This is the second of two reports.Refer to 2026095-2016-00123 for the first report.A report was received from (b)(6) stating the device infused within 2-hours and 2-hours and 30-minutes instead of 4-hours.The patient had headache and severe asthenia, the signs have since diminished.The room temperature was between 30°c and 35°c.The flow restrictor was taped to the patient's skin.No additional information was provided.

Manufacturer Narrative

The pump was returned used.The pump was refilled with 0.9% of saline using the repeater pump to the nominal value of 400ml.Infusion was verified and the flow accuracy test was performed after 4 hours of waiting time.After 3 hours of testing, the pump yielded a flow rate of 101.20ml/hr, which is within specifications with a +/-15% tolerance.The pressure pot was performed on the flow control tubing without the filter.The tubing was detached from the pump and connected to a pressure gauge.The average bladder pressure used was 8.17psi.The flow restrictor yielded a flow rate of 89.28ml/hr, which is within specifications with a +/-15% tolerance.The investigation summary concludes that fast flow was not observed for the returned sample.During the flow accuracy test, the pump met specifications.During pressure pot testing, the flow control tubing met specifications using the average bladder pressure.One of assignable cause for the failure was identified as use of the product at 30-35 c, which is which is higher than the recommended temperature, 20c.It is possible that temperature contributed to this event.It is unclear that if the patient was experienced user based on the information provided.It is the responsibility of the healthcare provider to ensure patient is educated in the proper use of the system.At this time for the fast flow, the root cause is determined to be inappropriate use of the product.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).

• Brand Name: SURGPN,400X100,HM PMP,-,EC,24
• 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.
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 5883414
• MDR Text Key: 53449881
• Report Number: 2026095-2016-00125
• 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,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: E401000
• Device Catalogue Number: 101355400
• Device Lot Number: 0201402443
• Other Device ID Number: ANP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/28/2016
• Initial Date FDA Received: 08/17/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR