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

Catalog Number 2C4702K

Device Problem Crack (1135)

Patient Problem No Patient Involvement (2645)

Event Date 05/29/2017

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a crack in the injection port of a small volume folfusor that made device not usable.There was no patient involvement.No additional information is available.

Manufacturer Narrative

One folfusor unit was received for analysis.The unit was returned to the plant containing approximately 100 ml of solution in the bladder.A visual inspection on the unit via the naked eye noted cracks located on the fillport.The cracks were white hazing which suggests alcohol solution may have likely been used to disinfect the fillport surface before and after filling the device with drug solution.The fillport is made of acrylic material and acrylic is sensitive to alcohol solution.When adequate amount of alcohol solution is applied on the fillport, cracks will appear on the fillport.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was verified.Should additional relevant information become available, a supplemental report will be submitted.

• 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; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6661218
• MDR Text Key: 78186083
• Report Number: 1416980-2017-05203
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/29/2017
• Device Catalogue Number: 2C4702K
• Device Lot Number: 17B053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2017
• 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