MAUDE Adverse Event Report: ICU MEDICAL, INC. IV INVUSION PUMP, VOLUMERIC PLUM 360; SET, ADMINISTRATION, INTRAVASCULAR

Model Number PLUM 360

Device Problems Device Alarm System (1012); Pumping Problem (3016); Air/Gas in Device (4062)

Patient Problems Pyrosis/Heartburn (1883); Pain (1994); Hot Flashes/Flushes (2153)

Event Date 10/11/2022

Event Type  malfunction  

Event Description

Pt receiving iv infusion for chemotherapy and saline.Pt reported to finish remaining hydration left.Rn adjusted pump to run remaining 500 cc over 30 min on a line.Approximately 30 min later, rn noted the line to have completely run dry but the infusion pump to still be running with no alarm alerting to air in line.The pump was immediately turn d off and disconnected.The rn noted air in line throughout all of the tubing and it appeared to be present in the vad line as well.The patient began rubbing her chest.Rn attempted to aspirate back on vad line and blood return noted.Vad line then flushed with ns 10 cc x2.Pt began to c/o indigestion and discomfort in chest and feeling hot.Pt was placed on left side and supplemental oxygen applied via face mask.Vs remained stable.Ekg performed and wnl.O2 removed.Pt monitored for an additional 30 min and reports feeling better and all symptoms have resolved.Pt educated to go to ed for further signs/symptoms.Pump was evaluated by clinical engineering department and the failure could not be duplicated.Cases have been registered with icu medical and the pumps are being sent to them for evaluation.

• Brand Name: IV INVUSION PUMP, VOLUMERIC PLUM 360
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.
• MDR Report Key: 15651441
• MDR Text Key: 302401207
• Report Number: MW5112767
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PLUM 360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White