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

Catalog Number D2C4711K

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

Manufacturing date -- may 24, 2016 ¿ may 26, 2016.The device was returned and an evaluation is complete.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection was performed with no issues noted.A functional flow rate test was performed with no issues noted.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 small volume folfusor had an under infusion issue.The pump was filled with 5fu and nacl and after the infusion time was elapsed, 40ml remained in the pump.The total fill volume was 120ml.This was identified during use.There was no patient injury or medical intervention associated with this event.

• Brand Name: FOLFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; irvine CA
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue, bldg 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6199699
• MDR Text Key: 63133437
• Report Number: 1416980-2016-18666
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• 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: 12/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: D2C4711K
• Device Lot Number: 16E029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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: 5FU, NACL
• Patient Age: 73 YR