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

Catalog Number 2C1063KP

Device Problems Filling Problem (1233); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

The lot was manufactured between june 1, 2017 - june 2, 2017.The device was received for evaluation containing approximately 50 ml of fluid in the bladder.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional flow rate test was performed with no issues noted.The flow rates were found to be within the product specification range.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The reported condition was not verified.Further information was provided by the hospital that the affected patient was non-compliant to the instructions given to him when infusing the pump.Examples of non-compliant behaviors cited were: not applying the flow restrictor and placing the pump at a level different to what was advised.Should additional relevant information become available, a supplemental report will be submitted.Proper user instructions are addressed in infusor lv portable elastomeric infusion system labeling.The labeling instructs the user that the infusor lv system is designed to operate at the nominal flow rate when the fill port and the distal end luer lock/flow restrictor are positioned at approximately the same height.Flow rate will decrease approximately 0.5% for every one inch (2.54 cm) the fill port is positioned below the distal end luer lock/flow restrictor and will increase approximately 0.5% for every one inch (2.54 cm) the fill port is positioned above the distal end luer lock/flow restrictor.A review of the label for the product family will be conducted.

Event Description

It was reported that a large volume infusor underinfused the medication.This issue was discovered after patient use.The infusor was filled with cefoxitin 12g and normal saline as diluent to a total volume of 240ml.Residual volume was 35ml.The cause of the underinfusion was the patient being non-compliant with the instructions.The non-complaints were further described as the patient not applying the flow restrictor and placing the pump at a level different to what was advised.There was no patient injury or medical intervention associated with this event.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: 7389068
• MDR Text Key: 104199701
• Report Number: 1416980-2018-01783
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00085412081366
• UDI-Public: (01)00085412081366
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/02/2018

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: Lay User/Patient
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: 2C1063KP
• Device Lot Number: 17F001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1