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

Catalog Number 2C1154KP

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2017

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a small volume infusor disconnected from the patient and leaked.There was a cut on the central part of the tubing of the device.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was not returned; however, photographs were received and evaluated.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection of the photographs showed evidence of broken tubing.It is unclear regarding the exact location on the device where the tubing is broken off because the multirate control module is not shown in the photos.The reported condition was verified, however the cause could not be determined from the images.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: 6667322
• MDR Text Key: 78400798
• Report Number: 1416980-2017-05277
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K011317
• 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: 08/03/2017

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: Other
• Device Catalogue Number: 2C1154KP
• Device Lot Number: 16E013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2017
• Initial Date FDA Received: 06/26/2017
• Supplement Dates Manufacturer Received: 07/14/2017
• Supplement Dates FDA Received: 08/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2016
• 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: MORPHINE
• Patient Age: 25 YR