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 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received, and an evaluation is complete.A device history record review revealed no issues that could have caused or contributed to the event.The device received incoming device evaluation assessment (idea).This evaluation included a visual assessment as well as functional testing.The device failed testing due to a intermittent keypad response.Service evaluation verified the intermittent keypad response.The cause was identified to be a failed keypad which was replaced.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During evaluation of a returned spectrum pump, the device had an intermittent keypad response.There was no patient involvement.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: 7657231
• MDR Text Key: 112995803
• Report Number: 1314492-2018-02245
• 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,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• 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: 05/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2018
• 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