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

Catalog Number 2C2009K

Device Problem Filling Problem (1233)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888)

Event Date 02/22/2021

Event Type  Injury  

Manufacturer Narrative

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 patient experienced an over infusion with a large volume infusor which resulted in abdominal pain.It was reported the infusion was completed in approximately 21 hours and 25 minutes instead of the expected 46 hours.It was reported the device contained 2850 mg of fluorouracil at 50 mg/ml and 173 ml of dextrose 5% for a final volume of 230 ml.The infusor is indicated to contain a fill volume of 250 ml.The cause of the over infusion was not reported.There was no report of external leakage.It was reported the patient was hospitalized for observation and was receiving filgrastim as a preventive measure.During hospitalization, the patient experienced gastro-intestinal irritation and rectal bleeding.The patient received supportive treatment for the events (no further details).At the time of this report, the patient was recovered from the events.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.The sample did not contain any residual fluid in the bladder.Visual inspection with the naked eye did not identify any abnormalities that could have contributed to the reported condition.Functional flow testing was performed and was found to be within the product specification range.The reported issue was not verified.The cause of the condition could not be determined.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: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11592306
• MDR Text Key: 243067336
• Report Number: 1416980-2021-01712
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412579399
• UDI-Public: (01)00085412579399
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Catalogue Number: 2C2009K
• Device Lot Number: 20J007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Manufacturer Received: 03/08/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention