MAUDE Adverse Event Report: HALYARD - IRVINE UNKNOWN ELASTOMERIC PUMP; ELASTOMERIC LFR

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problem Jaundice (2187)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.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 comp(b)(4).

Event Description

Halyard received a single report that referenced three different incidents, which were associated with separate units, involving three different patients.This is the second of three reports.Refer to 2026095-2016-00220 for the first patient.Refer to 2026095-2016-00222 for the third patient.Fill volume: 125 ml.Flow rate: unknown.Procedure: unknown.Cathplace: unknown.It was reported that a few patients experienced cholestatic jaundice associated with the use of elastomeric pumps.No further information was received.

• Brand Name: UNKNOWN ELASTOMERIC PUMP
• Type of Device: ELASTOMERIC LFR
• 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: 6155688
• MDR Text Key: 61810434
• Report Number: 2026095-2016-00221
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 0.25% BUPIVACAINE
• Patient Outcome(s): Other