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

Catalog Number 2C1155KP

Device Problem Filling Problem (1233)

Patient Problems Weakness (2145); Burning Sensation (2146)

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed on the returned unit and the results were found to be within the normal specification range for the product.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that reported a patient experienced an overinfusion of 5-fu with a multirate infusor.It was reported that the infusion finished in 48 hours instead of 96 hours and the patient experienced severe weakness and a burning sensation in the oral cavity.The infusor was filled with 288 milliliters of 5-fu, six grams, at a flow rate of 3ml/hour.The cause of the overinfusion of more than 30% above the expected rate was not reported.The patient required hospitalization due to the event and treatment was not reported.On an unreported date, the patient was recovered from the event and was discharged from the hospital.No additional information is available.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue, bldg 3; irvine CA 92614
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue, bldg 3; irvine CA 92614
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5297706
• MDR Text Key: 33503790
• Report Number: 1416980-2015-44404
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2015

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: Health Professional
• Device Expiration Date: 06/01/2017
• Device Catalogue Number: 2C1155KP
• Device Lot Number: 14F026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2015
• Initial Date FDA Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: ¿NS¿ (NORMAL SALINE), FRESENIUS
• Patient Outcome(s): Hospitalization
• Patient Age: 32 YR