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

Catalog Number S2C4704K

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that a small volume folfusor had a crack in its coil cap.This was noticed before filling and therefore before patient connection.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).The lot was manufactured from 03/25/2012 to 03/26/2012.The device was visually inspected, and a crack was observed on the coiled cap.The reported condition was confirmed.A review of all batch record documents was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Evaluation summary: the coil cap crack was caused by a misalignment that resulted in excessive stress during the assembly of the device.This malfunction is caused by an operator error.Training for the operators has been issued.If additional relevant information is obtained, then a follow-up mdr will be submitted.

• 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: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3720717
• MDR Text Key: 4233867
• Report Number: 1416980-2014-10735
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2014
• Device Catalogue Number: S2C4704K
• Device Lot Number: 12C068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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