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

Catalog Number 3570009

Device Problem False Alarm (1013)

Patient Problems Dyspnea (1816); Tachycardia (2095); Hot Flashes/Flushes (2153); Increased Respiratory Rate (2486)

Event Date 10/31/2022

Event Type  Injury  

Manufacturer Narrative

The user facility submitted medwatch (b)(4) for this event.Reporter provided an invalid serial number (b)(4).The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that shortly after starting a patient infusion of flolan with a spectrum iq pump, the patient became "briefly short of breath but resolved immediately".As per the reporter, "sometimes this happens after tubing changes".The reporter stated that a "short while later", the pump triggered an alarm.The nurse noted that an "upstream occlusion" alarm was generated.The nurse checked the lines and the clamps, and a "second nurse" also double-checked that the setup was correct.The patient then experienced "sudden and increasing sob" (shortness of breath), became tachypneic, and flushed, with a heart rate in the "130s".A new bag was connected to a new intravenous setup and loaded onto a "new pump [with] a new filter".The patient's symptoms resolved shortly after changing the bag.The patient was under observation ("team at bedside"), their heart rate was "recovering", their blood pressure was "stable", and receiving oxygen therapy.Patient was ¿currently stable at this time¿.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: 16158262
• MDR Text Key: 307293110
• Report Number: 1314492-2023-00019
• Device Sequence Number: 1
• Product Code: FRN
• 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: User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 3570009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/13/2023
• 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
• Treatment: FLOLAN
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White