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

Catalog Number D2C4009K

Device Problem Filling Problem (1233)

Patient Problems Palpitations (2467); Vascular System (Circulation), Impaired (2572)

Event Date 04/07/2016

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 not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced an over-infusion of 5-fu with the use of a folfusor.As a result, the patient experienced heart palpitations, strong sickness and circulatory troubles (no further detail was provided).The indication for the infusion or whether the patient was hospitalized as a result of the event was not reported.It was reported that a folfusor, filled with 62mls of 5-fu (fluorouracil) and sodium chloride (168ml) delivered the infusion ten hours faster than the expected delivery time and was completely infused after 36 hours instead of the intended 46 hours.The cause of the over-infusion was not reported.It was reported that there was no medical intervention given to the patient for the symptoms.No further information was provided regarding the patient outcome.No additional information is available.

• Brand Name: FOLFUSOR
• 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: 5641300
• MDR Text Key: 44744508
• Report Number: 1416980-2016-08656
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: D2C4009K
• Device Lot Number: 15K031
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/12/2016
• Date Device Manufactured: 10/21/2015
• 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: 5-FU (FLUOROURACIL)
• Patient Outcome(s): Other