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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fever (1858); Nausea (1970); Vomiting (2144); Myalgia (2238); Arthralgia (2355); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product - low-dose aspirin; simvastatin 40 mg daily.(b)(4).There is no information provided regarding the return of the actual complaint product to the manufacturer.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.(b)(4).Device not returned.

Event Description

Fill volume: 171 mg, flow rate: 2 mg/hr for 2 days, procedure: left inguinal herniorrhaphy, cathplace: surgical wound.Halyard received a single report that referenced three different incidents, which were associated with separate units, involving three different patients.This is the third of three reports.Refer to 2026095--2016-00224 for the second patient.It was reported that a clinical manager discovered an article titled ¿bupivacaine drug-induced liver injury: a case series and brief review of the literature." journal of clinical anesthesia (2016) 32, 137¿141.Patient 3 received general anesthesia for sedation, and was injected with 15 ml of 0.5% bupivacaine intraoperatively.The onq pump was put in at the surgical site, and contained 0.5% bupivacaine and infused medication at 2 mg/hr for 2 days.Total dosage received was 171 mg.The patient was discharge without complications.5 days after the surgery, the patient developed fevers, abdominal pain, nausea, vomiting, arthralgias, and myalgias.The patient's fevers resolved, but continued to have nausea and vomiting.The patient also had dark urine and acholic stools.The patient went to his primary care physician 20 days after the surgery for evaluation.The patient was treated and down-trending test results were observed.Liver function enzymes and bilirubin normalized within 1 month.

• Brand Name: ELASTOMERIC LFR
• Type of Device: UNKNOWN ONQ PUMP
• 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: 6179077
• MDR Text Key: 62525134
• Report Number: 0002026095-2016-00225
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 58 YR