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

Catalog Number 2C1063KP

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6) the device was manufactured july 14, 2016 ¿ july 16, 2016.The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph revealed an indentation mark on the tube.The cause of the indentation mark could not be determined.A nonconformance has been opened to address this issue.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

It was reported that the tubing of a large volume infusor ¿became punctured¿ during patient infusion, leading to a leak.This occurred approximately one hour before the end of the expected therapy time.The device was filled with piperacillin / tazobactam in 0.9% sodium chloride solution.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 ave; bldg 3; irvine CA 92614
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6203650
• MDR Text Key: 63260433
• Report Number: 1416980-2016-18713
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 12/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 2C1063KP
• Device Lot Number: 16G011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2016
• 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: PIPERACILLIN / TAZOBACTAM; SODIUM CHLORIDE 0.9%