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

Catalog Number 2C4009K

Device Problem Filling Problem (1233)

Patient Problems Dyspnea (1816); Nausea (1970); Vomiting (2144); Diaphoresis (2452)

Event Type  Injury  

Manufacturer Narrative

The events occurred on an unspecified date in (b)(6) 2021.(b)(6), should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced an over infusion with a folfusor device which resulted in palpitations, shortness of breath, sweaty, unrest, nausea, ¿deeply sedated arm¿, not being able to sleep and vomiting.The cause of the over infusion was not reported.The device contained naropin 0.2%, 280 ml.The pump was started post-operatively and approximately one hour and thirty-seven minutes later, the patient was discharged home in stable condition.It was reported ¿late in the evening¿ the symptoms began.The pump was removed approximately four and a half hours after discharge and ¿it appeared the pump was already half empty¿.The following day ¿midday¿, the patient was recovered.There was not report of a medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed, and the rates were found to be within product specification range.No device failure or malfunction was identified that could have caused or contributed to the reported event.The reported condition 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.

• Brand Name: FOLFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11991980
• MDR Text Key: 255961570
• Report Number: 1416980-2021-03613
• Device Sequence Number: 1
• Product Code: MEB
• 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: 07/20/2021

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 Catalogue Number: 2C4009K
• Device Lot Number: 20N024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2021
• Initial Date Manufacturer Received: 05/21/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 07/14/2021
• Supplement Dates FDA Received: 07/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other