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

Catalog Number IN2C9961KP

Device Problems Fluid/Blood Leak (1250); Scratched Material (3020)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

One single-use device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.No evidence of "scratches and scribbled" were identified during inspection.A functional leak test was performed by filling the device.During filling, a leak/backflow was observed from the fillport.Further inspection revealed that the cause of the leak/backflow problem was due to two glass fragments approximately 0.20 and 0.25 square mm in size, lodged under the device¿s checkband.The reported leak was verified.The most likely cause of glass fragments becoming lodged under the checkband is user filling technique.A glass ampoule used for filling the device without a filter can result in this type of event.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.

Event Description

This report summarizes 1 malfunction events.It was reported that a large volume infusor had "scratches and scribbled" on the outer part of the pump.This was identified prior to patient use.The customer proceeded to use the device for infusion.During infusion, the device leaked from the fillport.This event involved a patient with no patient consequences.No additional information is available.

• Brand Name: INFUSOR
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - IRVINE; irvine CA
• 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: 9252518
• MDR Text Key: 172597337
• Report Number: 1416980-2019-05978
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412517575
• UDI-Public: (01)00085412517575
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: IN2C9961KP
• Device Lot Number: 18J035
• Date Manufacturer Received: 09/30/2019
• Type of Device Usage: N
• Patient Sequence Number: 1