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

Catalog Number 2C1063KP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Device manufacture date: may 1, 2017 - may 2, 2017.The actual sample was received at the plant for analysis.Visual inspection on the returned unit noted no signs of bubbles inside the tubing line.The functional flow rate test was performed on the unit, and there was no evidence of bubbles.The flow rate was completed with continuous flow of fluid.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.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that air bubbles were noticed inside the line of an lv infusor.This event occurred during patient infusion.It was further reported that the bubble went to the patient.The device had been filled with flucloxacillin.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: 7419323
• MDR Text Key: 105164465
• Report Number: 1416980-2018-02016
• 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: 04/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2020
• Device Catalogue Number: 2C1063KP
• Device Lot Number: 17E003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2018
• 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