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

Device Problem Filling Problem (1233)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that twenty eight (28) unspecified large volume folfusors underinfused the medication; there was residual drug in the devices.The device contained flucloxacillin or benzylpenicillin.This was observed during a pilot research.An average residual volume of 28% remained in the devices, which is equivalent to 67.2ml per pump.In some case, 38% of the total volume remained after 24 hours, representing 81.6ml remaining in the device.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: NI
• 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 60073 ; 2242702068
• MDR Report Key: 19160188
• MDR Text Key: 340942586
• Report Number: 1416980-2024-01856
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2024

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/22/2024
• 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
• Treatment: BENZYLPENICILLIN; FLUCLOXACILLIN