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

Catalog Number 2C4702K

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

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

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a folfusor sv (small volume) leaked into the chamber.It was further reported that after filling the device with 71ml, the operator removed the syringe in order to attach the final one; a popping noise was heard.The device was inverted to be checked and cytotoxic medication leaked out of the chamber onto the work station.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3, h4 and h6: h4: the device was manufactured from january 16, 2020 - january 20, 2020.H10: the device was received for evaluation.During visual inspection, the bladder was observed ruptured.The external and internal surfaces of the bladder and the rupture line were microscopically examined for evidence of markings, abrasions, gouges, holes, or embedded particulate matter along with any surface defects on the stress-member for any signs of abnormality which may have caused the device to rupture.No signs of abnormality were found on the ruptured bladder.The reported condition was verified.The cause of the condition could not be determined, however, the potential for bladder ruptures exists as bladders are manufactured with rubber.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
• MDR Report Key: 12013329
• MDR Text Key: 256756618
• Report Number: 1416980-2021-03699
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412080154
• UDI-Public: (01)00085412080154
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C4702K
• Device Lot Number: 20A029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NA.