MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. SPECTRUM IQ INFUSION PUMP; PUMP, INFUSION

Lot Number 40153911

Device Problems Display or Visual Feedback Problem (1184); Obstruction of Flow (2423)

Patient Problems Adult Respiratory Distress Syndrome (1696); Tachycardia (2095); Hot Flashes/Flushes (2153); Increased Respiratory Rate (2486)

Event Date 10/31/2022

Event Type  malfunction  

Event Description

Patient due for flolan tubing and bag change this evening.The nurse spiked bag, primed through new primary tubing, filter and blue clave without issue.The nurse visualized, witnessed, and confirmed that flolan medication successfully primed through tubing and clave into medication cup to ensure no air bubbles and that tubing was ready for infusion.Connected new tubing to patient, all clamps unclamped, and started infusion, drops noted to be dripping from chamber.Patient briefly short of breath but resolved immediately, stated "sometimes this happens after tubing changes." short while later, pump beeping and patient called on call bell.The nurse into room immediately and message on pump stated, "upstream occlusion." nurse checked tubing, all clamps unclamped and second nurse also in room who also double-checked tubing was correct.Patient suddenly and increasingly sob (shortness of breath) tachypneic, flushed, hr 130's.Backup flolan bag scanned, verified by 2 nurses and old bag switched out, new bag hung with new tubing, new pump and new filter.Symptoms resolved shortly after changing bag.Team at bedside, hr recovering, bp stable, on o2.Ekg and cxr done per orders.Confirmed with pharmacy that new backup bag being made.Old pump and flolan with tubing set aside and labeled.Patient currently stable at this time.Pump evaluated by biomed dept.No immediate reason for alarm could be found.Manufacturer response for smart infusion pump, iq infusion pump (per site reporter) the manufacturer has been on-site.They continue to work with the hospital.

• Brand Name: SPECTRUM IQ INFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16003776
• MDR Text Key: 305715123
• Report Number: 16003776
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 40153911
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/19/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16425 DA
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Race: White