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

Catalog Number 2C4711K

Device Problem Backflow (1064)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/09/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a backflow leak was observed from the fill port of a small volume folfusor.The backflow out of the fill port was observed while filling the device with medication prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual device was received for evaluation.Visual inspection on the returned device via the naked eye noted evidence of leak at the fillport when the fillport cap was removed.Further inspection on the device revealed the cause of backflow was due to a particle measured to be 2.37 mm in length, stuck under the device checkband.The particle was identified to be acrylic material via fourier transform infrared spectroscopy (ftir) test.Acrylic is the material of the device stressmember.The reported condition was verified.The cause of the material under the checkband could not be determined; however, the most probable cause is related to small shaving getting stuck under the checkband during manufacturing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.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 CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - IRVINE; 17511 armstrong avenue; building 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 12601543
• MDR Text Key: 276118499
• Report Number: 1416980-2021-06163
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412082172
• UDI-Public: (01)00085412082172
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4711K
• Device Lot Number: 21C027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1