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

Catalog Number 2C4702K

Device Problem Filling Problem (1233)

Patient Problems Diarrhea (1811); Muscle Spasm(s) (1966)

Event Date 10/09/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 and the flow rate was found to be within product specifications.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Based on the sample evaluation result the reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced an overinfusion of 5-fu from a folfusor and as a result experienced a coronary artery spasm and diarrhea.The folfusor was filled with 4750 mgs.Of 5-fu for a total fill volume of 97 mls.It was reported that the folfusor was completely empty in 29 hours instead of the intended 48 hours.It was reported that the patient recovered without any medical intervention.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: 5222574
• MDR Text Key: 31167335
• Report Number: 1416980-2015-41792
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 11/13/2015

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: 05/01/2017
• Device Catalogue Number: 2C4702K
• Device Lot Number: 15E037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2015
• 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) 5-FLUOROURACIL (NON-BAXTER PRODUCT)
• Patient Outcome(s): Other
• Patient Age: 64 YR