MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE FLOGARD; PUMP, INFUSION, ELASTOMERIC

Catalog Number 2M8063F

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was serviced on-site by a field service technician.This is an ancillary service event.A visual inspection, functional testing, and an alarm log review were performed.During the force sensing resistor (fsr) testing and the alarm log review the f-38 alarm was identified.The cause of the alarm were damaged fsrs.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The pump has been removed from service.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During on-site service, the baxter service technician identified an f-38 alarm (malfunction in tube misloading detection circuitry) on a flo-gard infusion pump.Additional information is not available.

• Brand Name: FLOGARD
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 02573 ; SN 02573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 02573 ; SN 02573
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5406979
• MDR Text Key: 37435185
• Report Number: 1416980-2016-02483
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: MX
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2016

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: No Information
• Device Catalogue Number: 2M8063F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/1995
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1