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 01/26/2017

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 1500mg of vancomycin diluted with 240ml of 0.9% sodium chloride.The solution was completely infused after 21 hours.Six 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.

Manufacturer Narrative

The patient¿s doctor reported there was no patient harm due to the infusor pump over-infusion incident; further stating that ¿the patient had none of the known vancomycin side effects¿.Subsequently, the patient was changed to daptomycin due to continuing fevers which the patient completed this week.Upon further review of the clinical circumstances the baxter disposable device is no longer considered suspect product in this event.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 ¿ 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: 6365002
• MDR Text Key: 68535528
• Report Number: 1416980-2017-01703
• 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,Followup
• Report Date: 03/24/2017

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?: No
• 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
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2017
• 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