MAUDE Adverse Event Report: BAXTER HEALTHCARE - IRVINE INFUSOR; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2C1009KP

Device Problem Filling Problem (1233)

Patient Problem Seizures (2063)

Event Type  Injury  

Manufacturer Narrative

Date of event: the chemo treatment began on (b)(6) 2019 and the seizures occurred on (b)(6) 2019.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced an over infusion with an infusor pump which resulted in multiple seizures.It was reported the patient was undergoing a 46-hour chemo treatment (started on unreported time in the afternoon) with 480mg (dose banded) 5fu within 230ml civa.The following morning it was noted the infusor was ¿nearly empty¿.There was no liquid or precipitate noted around the infusor.It was reported ¿shortly after¿, the patient experienced seizure like activity and presented to the emergency department (ed), where the infusor was removed.While in the ed the patient experienced three seizures.The patient was administered unspecified ¿anti-seizure meds¿ (no further details).It was reported the pump was attached via a port and kept at chest level within a canvas container.The cause of the over infusion was not reported.At the time of this report, the patient was hospitalized, ¿stable and undergoing observation¿.No additional information is available.

Manufacturer Narrative

Additional information: the actual device was not available; however, a companion sample was received for evaluation.Visual inspection of the companion sample with the naked eye did not identify any abnormalities that could have contributed to the reported condition.Functional flow rate testing was performed on the companion sample and was found within the product specification range.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; irvine CA
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8802995
• MDR Text Key: 151450602
• Report Number: 1416980-2019-03848
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081373
• UDI-Public: (01)00085412081373
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/23/2019

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/02/2022
• Device Catalogue Number: 2C1009KP
• Device Lot Number: 19B008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 07/29/2019
• Supplement Dates FDA Received: 08/23/2019
• 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: N
• Patient Sequence Number: 1
• Treatment: 5% DEXTROSE 1000ML; FLUOROURACIL (NONBAXTER)
• Patient Outcome(s): Hospitalization; Required Intervention