MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC VIGILANCE & MED AFFAIRS N/A; HEPARIN LOCK FLUSH

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Seizures (2063)

Event Type  Injury  

Event Description

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.

• Brand Name: N/A
• Type of Device: HEPARIN LOCK FLUSH
• Manufacturer (Section D): FRESENIUS KABI USA, LLC VIGILANCE & MED AFFAIRS; three corporate drive; lake zurich IL 60047
• Manufacturer Contact: elizabeth hartnett ; vigilance & medical affairs; three corporate drive; lake zurich, IL 60074 ; 8005517176
• MDR Report Key: 8361745
• MDR Text Key: 136866573
• Report Number: 3002733956-2019-00001
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• PMA/PMN Number: K092938
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 02/01/2019

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?: No
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 22 YR
• Patient Weight: 84