MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM PC UNIT; PUMP, INFUSION

Model Number 8015

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Coagulation Disorder (1779); Intracranial Hemorrhage (1891); Hyperglycemia (1905); Low Blood Pressure/ Hypotension (1914); Respiratory Distress Syndrome of Newborns (2046); Hypernatremia (2242); Premature Labor (2465); Respiratory Acidosis (2482)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

The customer¿s reported experience that a syringe module overinfused when the customer intended to program a 0.34 ml infusion over 15 minutes, yet the entire contents of the syringe was empty after 15 minutes, was determined through log review to be a programming issue.The inspection process performed on the syringe module found no irregularities.Log analysis results: the syringe module sn (b)(4) was the only device that was returned.The pcu sn (b)(4) was not returned for investigation.Although requested, the customer did not returned the pcu for investigation stating that the pcu was placed back into service with no issues.The reported date and time was 02 december 2020 between 07:00:00 pm and 12:00:00 am.Reviewed the syringe module error log and found no errors occurring during the date and time of the reported event.Reviewed the syringe module event log for recorded entries that occurred during the date and time of the reported event.On (b)(6) 2020: 08:04:16 pm, the user selects the syringe module and selects the bd 3 ml syringe with the recorded volume of 0.8952 ml.08:07:34 pm, the user programmed an infusion at the rate of 0.345 ml/h with the vtbi of 0.34 ml.The calculated duration of this infusion was 1 hour.08:15:16 pm, the syringe module was channeled off.09:18:39 pm, the user selects the syringe module and selects the bd 3 ml syringe with the recorded volume of 1.191 ml.09:19:27 pm, the user programmed an infusion at the rate of 4.764 ml/h with the vtbi of 1.191 ml.The calculated duration of this infusion was 15 minutes.09:34:34 pm, ¿syringe empty¿ message displayed.09:39:09 pm, the syringe module was channeled off.The administration set was not returned for this investigation, therefore it is unknown if the set may have contributed to the customer¿s experience.The root cause of the customer¿s reported experience that a syringe module overinfused was a programming issue.A review of the device history record showed the device had a manufacture date of 04/03/2015.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap for sn (b)(4) was performed which confirmed that this device was not involved in a production failure which correlates to the customer reported issue.A review of the complaint history record was performed for sn (b)(4) which did not confirm similar complaints with the same or related failure mode for this customer.

Event Description

It was reported that a syringe pump module overinfused insulin between 7pm and midnight on (b)(6) 2020, and the premature neonate patient died the following day on (b)(6) 2020 at 1432.The patient was being treated for profound metabolic acidosis and bilateral grade 3 intraventricular (cranial) hemorrhage, which never resolved despite maximal supportive measures.The patient was receiving iv insulin along with calcium gluconate and sodium bicarbonate infusions due to metabolic derangements including hyperkalemia, causing peaked t-waves on ecg (electrocardiogram).The patient was also on maximal vasopressor support (20mcg/kg/min dopamine and dobutamine) and stress dose hydrocortisone steroid replacement.The patient had developed anemia and coagulopathy during the nicu course, and had also required transfusions of packed red blood cells and fresh frozen plasma.The customer reported that "staff used insulin iv push on 12/2 sometime between 7pm and midnight, the dose was (b)(6) units and diluent 0.34mls the pump was told to give it over 15 minutes.Patient weight was (b)(6) instead of giving 0.34mls it gave the entire syringe which was approximately 1.5mls- after about 15 minutes the pump alarmed syringe empty." the nurse was in the room and heard the syringe pump alarm when they found the syringe was unexpectedly empty.The customer stated that the "overinfusion of the insulin did not lead to this patient's death.Blood glucose was 476 before bolus and 456 after bolus." following decompensation over the course of the evening of (b)(6) and the morning of (b)(6), the patient continued to decline due to persistent and unremitting metabolic acidosis (with associated electrolyte abnormalities) despite maximal supportive measures.Following multiple discussions between the family and the primary neonatologist today, it was recommended that full intensive care be withdrawn.Gradually, over the course of the morning of (b)(6), the patient decompensated further, and the neonate was pronounced dead at 14:32.The parents declined autopsy.The customer stated that the "infant¿s death was unrelated to the insulin over infusion.".

• Brand Name: ALARIS SYSTEM PC UNIT
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: shari lynn groth ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11489795
• MDR Text Key: 240598786
• Report Number: 2016493-2021-29877
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801518
• UDI-Public: 10885403801518
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8015
• Device Catalogue Number: 8015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Weight: 69