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

Model Number 8015

Device Problems Device Alarm System (1012); Computer Operating System Problem (2898)

Patient Problems High Blood Pressure/ Hypertension (1908); Irritability (2421)

Event Date 09/30/2022

Event Type  Injury  

Manufacturer Narrative

Bd technical support troubleshoot with customer over the phone.A follow up report will be submitted once the failure investigation has been completed.Per 803.52(f)(11)(iii) the information provided represents all of the known information at this time.The complainant or reporter was unable or unwilling to provide any further patient, product, or procedural details to the manufacturer.

Event Description

It was reported a recurrent "alaris pcu operating system error." the nurse went to set-up a new precedex syringe on syringe module.After the pump was scanned and the nurse was about to start drip, the pcu and other modules allegedly shut down, described as "a quick, unexpected, and uninterruptable full shutdown of the pc and connected channels, with a full wipe of the memory of the current patient, ongoing meds, library profile, everything." the nurse had to turn pump back on, drips that were running were reportedly no longer able to be restored after the pcu shut down.The morphine was one of the drips infusing via the device.The morphine infusion was then turned off for a couple of minutes.The nurse had to rescan and restart morphine drip, along with intravenous piggybacks and arterial line fluids.It was then noticed that the morphine drip was off and the patient was having a persistent pulmonary hypertension (pphn) episode where sedation medications would have helped the patient recover.Once a new syringe was ordered, the new syringe scanned fine, and did not shut down the pumps when started.It was also reported that the issue also occurred at three different occasions ("3 shutdowns").The nurse "tossed that medication (and label) and requested a new syringe and label be sent up which she put in the fridge." the night shift nurse was just preemptively setting up the precedex drip for use on dayshift, not to deliver at that time.When the setup first shutdown, the nurse turned it back on and tried immediately to rescan the precedex syringe but it lead to "crashing "the pcu again.The nurse then swapped the precedex to a different pcu and to a different syringe module that was already attached.The nurse scanned the medication, and it reportedly crashed again.The nurse then disposed of the syringe, and had to restore this pcu manually also.This is when the new syringe was ordered, and placed in the fridge.The nurse didn¿t attempt again, but did gave dayshift nurse a warning that this happened, and what the nurse had done to troubleshoot it.The dayshift rn used this new syringe and label in the same fashion and "had a repeat shutdown." the clinicians had thought there may have been something wrong with the label from pharmacy, and so another new syringe was sent after getting a new epic (electronic medical record) order.The issue reportedly occurred four times at the following times: 0359, 0401, 0417, and 0913 on (b)(6) 2022.There was a "mild to moderate harm" as a result of the event.It was noted that the last crash occurred at a time when the patient was needing sedation to "break a hypertensive spell." the customer added that "on the last event, after the pcu failed the patient became increasingly agitated to the point that manual/hand bagging at 100% fio2 was required to help control effective respirations.Additionally, a prn dose (of ativan) had to be used during this patient episode, that otherwise wouldn¿t have been needed.Recovery was noted within the hour [a return to baseline], and thankfully no ongoing or persistent issues have been noted with the patient at this time." the clinician added that "neonatal patient complicates this, as the outcome isn¿t always immediately evident." it was also reported by the hospital's clinical technician that a serial number discrepancy on the pcu, between what was displayed on alaris system maintenance and the "sticker" on the device.Additionally, it was reported a discrepancy between the internal and external serial numbers of the pcu, which was noted by the hospital's clinical technician when the devices were sent to them after the event.The customer stated that "the discrepancy was revealed to be a error by a bioengineering tech, during a prior repair." the barcode label attached to the pcu's rear case (noted not to be the original manufacturer's sticker) is different form the internal device serial number.The customer added that this was due to "the logic board was replaced and that was the source of the" other serial number.Hospital's bioengineering staff wasn¿t able to tell if that incorrect number was accidentally input when the board was flashed, or if it wasn¿t correctly overwritten at the same time.

Manufacturer Narrative

Omit : b21 - type of investigation not yet determined, c21 - results pending completion of investigation, d16 - conclusion not yet available.A device history record review is performed on each device reported in a mdr reportable event along with other methods of investigation as coded in section h6 of this mdr report.

Event Description

It was reported a recurrent "alaris pcu operating system error." the nurse went to set-up a new precedex syringe on syringe module.After the pump was scanned and the nurse was about to start drip, the pcu and other modules allegedly shut down, described as "a quick, unexpected, and uninterruptible full shutdown of the pc and connected channels, with a full wipe of the memory of the current patient, ongoing meds, library profile, everything." the nurse had to turn pump back on, drips that were running were reportedly no longer able to be restored after the pcu shut down.The morphine was one of the drips infusing via the device.The morphine infusion was then turned off for a couple of minutes.The nurse had to rescan and restart morphine drip, along with intravenous piggybacks and arterial line fluids.It was then noticed that the morphine drip was off and the patient was having a persistent pulmonary hypertension (pphn) episode where sedation medications would have helped the patient recover.Once a new syringe was ordered, the new syringe scanned fine, and did not shut down the pumps when started.It was also reported that the issue also occurred at three different occasions ("3 shutdowns").The nurse "tossed that medication (and label) and requested a new syringe and label be sent up which she put in the fridge." the night shift nurse was just preemptively setting up the precedex drip for use on dayshift, not to deliver at that time.When the setup first shutdown, the nurse turned it back on and tried immediately to rescan the precedex syringe but it lead to "crashing "the pcu again.The nurse then swapped the precedex to a different pcu and to a different syringe module that was already attached.The nurse scanned the medication, and it reportedly crashed again.The nurse then disposed of the syringe, and had to restore this pcu manually also.This is when the new syringe was ordered, and placed in the fridge.The nurse didn¿t attempt again, but did gave dayshift nurse a warning that this happened, and what the nurse had done to troubleshoot it.The dayshift rn used this new syringe and label in the same fashion and "had a repeat shutdown." the clinicians had thought there may have been something wrong with the label from pharmacy, and so another new syringe was sent after getting a new epic (electronic medical record) order.The issue reportedly occurred four times at the following times: 0359, 0401, 0417, and 0913 on 30 september 2022.There was a "mild to moderate harm" as a result of the event.It was noted that the last crash occurred at a time when the patient was needing sedation to "break a hypertensive spell." the customer added that "on the last event, after the pcu failed the patient became increasingly agitated to the point that manual/hand bagging at 100% fio2 was required to help control effective respirations.Additionally, a prn dose (of ativan) had to be used during this patient episode, that otherwise wouldn¿t have been needed.Recovery was noted within the hour [a return to baseline], and thankfully no ongoing or persistent issues have been noted with the patient at this time." the clinician added that "neonatal patient complicates this, as the outcome isn¿t always immediately evident." it was also reported by the hospital's clinical technician that a serial number discrepancy on the pcu, between what was displayed on alaris system maintenance and the "sticker" on the device.Additionally, it was reported a discrepancy between the internal and external serial numbers of the pcu, which was noted by the hospital's clinical technician when the devices were sent to them after the event.The customer stated that "the discrepancy was revealed to be a error by a bioengineering tech, during a prior repair." the barcode label attached to the pcu's rear case (noted not to be the original manufacturer's sticker) is different form the internal device serial number.The customer added that this was due to "the logic board was replaced and that was the source of the" other serial number.Hospital's bioengineering staff wasn¿t able to tell if that incorrect number was accidentally input when the board was flashed, or if it wasn¿t correctly overwritten at the same time.

• Brand Name: ALARIS SYSTEM
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: brett wilko ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 15672130
• MDR Text Key: 302396325
• Report Number: 2016493-2022-214258
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801518
• UDI-Public: (01)10885403801518
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

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 Model Number: 8015
• Device Catalogue Number: 8015 ALARIS PCU 1.5 MODULE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/03/2022
• Initial Date FDA Received: 10/26/2022
• Supplement Dates Manufacturer Received: 10/03/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2008
• 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 Outcome(s): Required Intervention
• Patient Sex: Male