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

Catalog Number IN2C1155KP

Device Problem Filling Problem (1233)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a multirate infusor underinfused during a patient infusion.The expected therapy time was 46 hours.The reporter stated that after 48 hours, there was drug remaining in the device.The device had been filled with fluorouracil (5-fu).There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The lot was manufactured from october 25, 2018 - october 29, 2018.H0: the device was received for evaluation.A visual inspection was performed using the naked which eye did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate testing was performed with no issues noted; rate was found within specification range.The device was found to be conforming product.The reported condition was not verified.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: 9513433
• MDR Text Key: 172598538
• Report Number: 1416980-2019-07133
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412517544
• UDI-Public: (01)00085412517544
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

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: IN2C1155KP
• Device Lot Number: 18K036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2020
• Initial Date Manufacturer Received: 11/30/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 01/08/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLUORURACIL