MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SPECTRUM IQ INFUSION PUMP; PUMP, INFUSION

Catalog Number 3570009

Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/14/2023

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.Evaluation included a visual assessment as well as functional testing.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.During evaluation, the device had a detached speaker which reduced the audio level.The rear case requires replacement to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During evaluation of a returned spectrum iq pump, the device had a reduced audio level.No additional information is available.

• Brand Name: SPECTRUM IQ INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• 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: 16686164
• MDR Text Key: 312761226
• Report Number: 1314492-2023-01187
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 00085412610900
• UDI-Public: (01)00085412610900
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K222048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 3570009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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