MAUDE Adverse Event Report: CAREFUSION ALARIS SECONDARY SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number SEC TUBING

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Seizures (2063)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that patient was receiving keppra via ivp as a secondary and normal saline was set up as primary for carrier fluid.It was noted at the time of infusion to be completed, it switched over to the carrier fluids.There was still approximately 1/3 of the keppra 100 ml remaining in bag and still needed to be administered.The infusion was restarted for the 1000 mg/100 ml rate, at the end of this infusion time, it was noted that there was still medication remaining in the bag to be infused.The pump was restarted for the 3rd time for patient to receive the total ordered dosage.Patient was brought to the ed after having a grand mal seizure and was admitted to icu after having another grand mal seizure while in the ed.

• Brand Name: ALARIS SECONDARY SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9574988
• MDR Text Key: 174515627
• Report Number: 9616066-2020-00085
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SEC TUBING
• Device Catalogue Number: SEC TUBING
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRI TUBING, THERAPY DATE (B)(6) 2019
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Weight: 65