N/A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-02-22 for N/A manufactured by Fresenius Kabi Usa, Llc Vigilance & Med Affairs.

Event Text Entries

[136866573] Seizures; convulsions (seizure). Country of occurrence: usa. This is a spontaneous case received from a consumer (patient`s mother) that refers to a (b)(6) year old female patient of unspecified ethnicity. Patient`s medical history included allergy to sulfa, daily seizures, porphyria, von willibrand disease, and drug addiction. Concomitant medications, alcohol and tobacco exposure history were not provided. Relevant tests/laboratory data, including dates were not provided. On an unspecified date approximately one year ago, the patient received monthly intravenous heparin lock flush for port patency and experienced seizures and convulsions. At times, the patient would need to be taken to the emergency room for the seizures and convulsions, where she would be treated with keppra and then discharged. Heparin lock flush manufacturer, concentration, form of administration, dose, specific therapy dates, lot number with expiry dates, duration of therapy to reaction onset, and action taken with product were not provided. The reporter implied causality, but stated she was not sure regarding the onset of the events in relation to the use of heparin lock flushes and it was unknown if the product caused the events. Event outcomes were not recovered. Additional information has been requested. Medical assessment: the events of seizure are more likely due to the patient's pre-existing seizure disorder which causes her to have daily seizures.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3002733956-2019-00001
• MDR Report Key: 8361745
• Report Source: CONSUMER
• Date Received: 2019-02-22
• Date of Report: 2019-02-01
• Date Mfgr Received: 2019-02-01
• Date Added to Maude: 2019-02-22
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: ELIZABETH HARTNETT
• Manufacturer Street: VIGILANCE & MEDICAL AFFAIRS THREE CORPORATE DRIVE
• Manufacturer City: LAKE ZURICH IL 60074
• Manufacturer Country: US
• Manufacturer Postal: 60074
• Manufacturer Phone: 8005517176
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: N/A
• Generic Name: HEPARIN LOCK FLUSH
• Product Code: NZW
• Date Received: 2019-02-22
• Model Number: N/A
• Catalog Number: N/A
• Lot Number: N/A
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: FRESENIUS KABI USA, LLC VIGILANCE & MED AFFAIRS
• Manufacturer Address: THREE CORPORATE DRIVE LAKE ZURICH IL 60047 US 60047

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other; 2. Required No Informationntervention	2019-02-22