MAUDE Adverse Event Report: BAXTER HEALTHCARE - MEDINA SPECTRUM INFUSION PUMP

Catalog Number 35700BAX

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received, and an evaluation is complete.The device received incoming device evaluation assessment (idea).This evaluation included a visual assessment as well as functional testing.The device failed idea testing due to a delayed keypad response.Service evaluation verified the delayed keypad response.The cause was identified to be a failed processor printed circuit board which was replaced.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During evaluation of a returned spectrum infusion pump device it experienced a delayed keypad response.No additional information is available.

• Brand Name: SPECTRUM INFUSION PUMP
• Type of Device: INFUSION PUMP
• Manufacturer (Section D): BAXTER HEALTHCARE - MEDINA; medina NY
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDINA; 711 park ave; medina NY 14103
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7660118
• MDR Text Key: 113076651
• Report Number: 1314492-2018-02259
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042121
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2018

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: Health Professional
• Device Catalogue Number: 35700BAX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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