MAUDE Adverse Event Report: PLUM 360¿ INFUSER; PUMP, INFUSION

Catalog Number 300100413

Device Problem Use of Device Problem (1670)

Patient Problem Respiratory Arrest (4461)

Event Date 07/14/2021

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation.

Event Description

The event involved a plum 360 infusion pump that the customer reported an issue with the pump not stopping when the nurse pressed stop.The patient was having an anaphylactic reaction to an unspecified antibiotic.The pump set up was the primary line with the antibiotic hanging on the secondary line.The nurse was unsure of whether or not the mode on the pump was piggyback or concurrent so she went through the motions and tested the pump both ways.In both scenarios (concurrent and piggyback) she had the secondary line infusing, pressed stop, and the pump continued to pump because the machine asked which line was needed to be stopped.The customer stated in an emergent situation like this, the stress is elevated and the nurse did not see that the pump did not stop.The customer does not believe the pump malfunctioned per the manufacturer¿s intention.There was no event alarm that the customer knows of.The patient status before the incident was stable, during the incident was in respiratory distress, and after the event the patient was intubated.The customer stated the patient went from being stable to being intubated due to severe anaphylactic reaction.

Manufacturer Narrative

Additional information in section a2, a3, b5, and concomitant product.

Event Description

Additional information received from the customer stating the patient was seen in the emergency department on (b)(6) 2021 for an area of redness, pain and swelling on the right lower extremity.The patient was seen by her primary care physician on (b)(6) 2021 for follow up and it was determined the patient had failed oral antibiotics and was sent to the emergency department for an order of ancef 1gm iv.At 1325 the patient started coughing and reported she could not breathe and respirations ceased.The nurse pressed the ¿stop¿ button on the pump.The patient received epinephrine and famotidine which were unsuccessful in completely alleviating the symptoms.At 1348 she was successfully intubated and the patient received.Epinephrine and decadron.An immediate post huddle revealed the pump had continued to pump after the nurse pressed the stop button.Another nurse came along behind the first nurse and completed turning off the pump as there was a no-action alarm going off by this time.The patient was extubated on the 15th and remained in the hospital until she was deemed safe for discharge on the 19th.The patient has seemed to have recovered from the event and as of this time, no long-term problems have been identified.

Manufacturer Narrative

The pump was not returned to the service hub, therefore limited analysis could be performed to determine a probable cause.A review of the pump¿s service history, event/alarm logs, and device history record could not be performed because no serial number was provided.It is important to note that when the plum 360 pump is running on two lines (concurrent and/or piggyback), when the stop button is pressed then an additional step is required for the user to choose which line to stop.The customer further states, ¿that they don¿t believe that the pump malfunctioned per manufacturer¿s intention.¿ upon the review of all given information, it was determined that the pump performed as expected.

• Brand Name: PLUM 360¿ INFUSER
• Type of Device: PUMP, INFUSION
• MDR Report Key: 12323554
• MDR Text Key: 266564709
• Report Number: 9615050-2021-00115
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Public: ++M33530010041311$$+7/16D
• Combination Product (y/n): N
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 300100413
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/23/2021
• 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
• Treatment: ANCEF 1GM IV, MFR UNK
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 70 YR