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

Model Number N/A

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

Patient Problem Seizures (2063)

Event Type  Injury  

Event Description

Convulsions (convulsions, seizure).Country of occurrence: usa.Case reference number (b)(4) is a spontaneous case received from a physician that refers to a patient (presumed adult) of unknown age, gender and ethnicity.Patient`s medical history, concomitant medications, drug allergy, alcohol and tobacco exposure history were not provided.Relevant tests/laboratory data, including dates were not provided.On an unspecified date, the patient received heparin lock flush solution (100 usp units per ml, ndc (b)(4)) for an unknown indication and experienced convulsions.Heparin lock flush solution indication, dose, frequency, route, 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.Event treatment and outcome were unknown.Additional information has been requested.Medical assessment: the patient`s unknown age, ethnicity, gender, medical history, concurrent disease processes, concomitant medications, drug allergy, alcohol and tobacco exposure history were not provided and may have contributed to the event.Relevant tests/laboratory data, including dates, were not provided.Heparin lock flush solution indication, dose, frequency, route, therapy dates, lot number with expiry dates, duration of therapy to reaction onset, and action taken with product were not provided.

• Brand Name: N/A
• Type of Device: HEPARIN LOCK FLUSH
• Manufacturer (Section D): FRESENIUS KABI USA, LLC; vigilance competence center lz; three corporate drive; lake zurich IL 60047
• Manufacturer Contact: vigilance competence center lz; three corporate drive; lake zurich, IL 60047 ; 8005517176
• MDR Report Key: 8689884
• MDR Text Key: 147712285
• Report Number: 3002733956-2019-00002
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2019
• 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