MAUDE Adverse Event Report: AVANOS MEDICAL - IRVINE UNKNOWN ELASTOMERIC PUMP

Model Number UNKNOWN

Device Problem No Apparent Adverse Event (3189)

Patient Problems High Blood Pressure/ Hypertension (1908); Nausea (1970); Vomiting (2144); Dizziness (2194)

Event Date 03/16/2019

Event Type  malfunction  

Manufacturer Narrative

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.All information reasonably known as of 05-apr-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.Avanos medical, inc.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 avanos medical, inc.Complaint database and identified as complaint (b)(4).

Event Description

Fill volume: 270 ml, flow rate: 2 ml/hr, procedure: spinal stenosis, cathplace: near spine, date of procedure: (b)(6) 2019.It was reported the patient went to the emergency department (ed) on (b)(6) 2019 for complaints of nausea, vomiting and dizziness.These symptoms started shortly after the patient went home on (b)(6) 2019 following a spinal stenosis stimulator placement.In the ed the patient had an extremely high blood pressure (bp), 200/100 mm/hg, and was kept in the ed to decrease the bp, and further additional monitoring.The pump was never clamped at this point and the patient was given intravenous (iv) fluids for hydration, administered medication for nausea and vomiting (n/v), and kept on bed rest.The family member was advised to clamp the patient's pump and see how he was feeling in 4 to 6-hours.Additional information received (b)(6) 2019 stated the hospital staff did not think that the elevated blood pressure was caused by the pump.The family member stated that after the pump was clamped for 4-hours, all of the patient's symptoms resolved and he was able to be discharged the next morning from the emergency department.The pump still had medication in it when the pump was removed by the staff registered nurse (rn).

• Brand Name: UNKNOWN ELASTOMERIC PUMP
• Type of Device: UNKNOWN ELASTOMERIC PUMP
• Manufacturer (Section D): AVANOS MEDICAL - 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: 8489380
• MDR Text Key: 141486190
• Report Number: 2026095-2019-00054
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2019

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: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/14/2019
• Initial Date FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 109