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

Catalog Number 2C1063KP

Device Problem Filling Problem (1233)

Patient Problem Injury (2348)

Event Date 01/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device was manufactured between: 16sep2016 and 19sep2016.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A patient experienced an overinfusion while connected to a large volume infusor.The device was filled with 1500 mg of vancomycin diluted with 240 ml of 0.9% sodium chloride.The infusor was connected to the patient at 0700 and was found to be empty at an unknown time.Three days later, the patient was re-admitted to the hospital for estimated glomerular filtration rate, high creatinine and high vancomycin levels (exact levels were not reported).The cause of the over-infusion, treatment for the event, and the patient¿s outcome were not reported.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; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6365180
• MDR Text Key: 68553493
• Report Number: 1416980-2017-01708
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K071222
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/28/2017

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 Expiration Date: 09/01/2019
• Device Catalogue Number: 2C1063KP
• Device Lot Number: 16J023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: VANCOMYCIN/SODIUM CHLORIDE 0.9
• Patient Outcome(s): Hospitalization