MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE; PUMP, INFUSION

Model Number 8100

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Electrolyte Imbalance (2196)

Event Date 10/05/2019

Event Type  Injury  

Manufacturer Narrative

The customer requests event log review.The event logs have not been received.A follow up report will be submitted with evaluation results should the logs be received for evaluation.Volume overload secondary to nephrotic syndrome; lower extremity cellulitis.The patient experience hypokalemia, customer stated;"but it is difficult to attribute this to possible inadvertent changes in the fluid rate because his rate was intentionally increased and his dose of metolazone was also increased".No devices received, log review only.

Event Description

It was reported that on (b)(6) at 1820 a primary infusion of bumetanide (25 mg/100 ml) was programmed to infuse at a rate of 0.5 mg/hr.(2 ml/hr.), as stated by customer ¿should have lasted until approximately on 10/5/19 at 18:00.¿ the user hung 2nd bag (25 mg/100 ml) on (b)(6) 2019 at approximately 12:17 (customer stated:¿ approximately 4 hrs.Sooner than expected); the rate remained at 2 ml/hr.And the bag should have lasted until 12:00 on 10/7.¿ on (b)(6) approximately 02:00 the bag was emptied (as stated by customer the infusion: ¿was about 10 hrs.Sooner than expected").The nurse mixed a new bumex drip (25 mg/100 ml) which was hung around 02:16 on (b)(6) per customer stated; ¿this bag should have lasted until around 02:00 on (b)(6) the next bag was hung on 10/8 at approximately at 2100 ( customer stated; ¿5 hrs.Sooner than expected¿).This pattern continued on and off while the patient was on the infusion.On (b)(6) 2019 at around 10:00 the rate was changed to 3 ml/hr.(0.75 mg/hr.); at round 10:38 that same day the rate was changed to 4 ml/hr.(1 mg/hr.) and stayed at this rate until (b)(6) 2010 at apx.09:45 when the infusion was stopped.The customer stated that the patient experience hypokalemia however the customer stated: ¿it was difficult to attribute this to possible inadvertent changes in the fluid rate because his rate was intentionally increased and dose of metolazone was also increased.The event occurred in the critical care.

Event Description

The customer reported that bumex (25mg/100ml) was initiated on (b)(6) 2019 at 18:20 at 0.5 mg/hr (2 ml/hr) for a duration 48hrs.Until approximately on (b)(6) 2019 at 18:00.On (b)(6) 2019 at approximately 12:17 (4 hours sooner than expected) another bag was hung.On (b)(6) 2019 approximately 02:00 (10 hrs.Sooner than expected) the bag was empty.The nurse mixed a new bumex drip (25 mg/100 ml) which was hung at approximately 02:16 on (b)(6) 2019.On (b)(6) 2019 approximately 21:00 another bag was hung (5 hrs.Sooner than expected).This pattern continued on and off while the patient was on the infusion.On (b)(6) 2019 at approximately 10:00 the rate was changed to 3 ml/hr.(0.75 mg/hr.); at approximately 10:38 that same day the rate was changed to 4 ml/hr.(1 mg/hr.) and stayed at this rate until (b)(6) 2019 at approximately 09:45 when the infusion was stopped.The critical care patient experienced hypokalemia however the customer stated: ¿it was difficult to attribute this to possible inadvertent change in the fluid rate because the infusion rate was intentionally increased and the dose of metolazone was also increased.".

Manufacturer Narrative

Correction on initial report: b.2 & g.3 (disregard other).Additional information provided: d.4, d.11 & h.4.The report of infusing faster than expected was not confirmed.The pump module was not returned for investigation.The pcu event log contained no obvious programming errors that would result in the reported event.There were no alarms observed during the entire period reviewed that would suggest the fluid container emptied earlier than it should have.The starting/ending volume of the fluid container cannot be determined through log review.The volumes recorded as being infused for the first three instances match up with the durations of the infusion.The fourth instance confirms the rate changes that were reported however the device was channeled off at 11:44 am on (b)(6) 2019 and not at 9:45 am on 2019 as was reported.The event description appears to describe four separate instances of the bumex infusion.First: the first instance shows pump module s/n (b)(6) was programmed to infuse bumetanide continuous 25mg/100ml (drugid 61) at 6:16 pm on (b)(6) 2019.The user entered 2ml/hr for the rate, which made the dose 0.5mg/hr.The user entered 90ml for the vtbi, which would infuse over 45 hours and not 48 hours as was reported.The infusion ran until 10:46 am on (b)(6) 2019 when the device was channeled off.There were no alarms prior to the user channeling the device off.The volume recorded as being infused during this period was 76.502ml.The infusion ran for 40 hours and 30 minutes during this period however the device was not infusing for approximately 2 hours and 13 minutes due to being channeled off, delay programming or patient side occlusion alarm.Second: the second instance shows pump module s/n (b)(6) was programmed to infuse bumetanide continuous 25mg/100ml (drugid 61) at 12:10 pm on (b)(6) 2019.The user entered 2ml/hr for the rate, which made the dose 0.5mg/hr.The user entered 95ml for the vtbi, which would infuse over 47.5 hours.The infusion ran until 2:17 am on (b)(6) 2019 when the user changed the vtbi of the bumetanide continuous 25mg/100ml (drugid 61) infusion running at 2ml/hr to 100ml.The volume recorded as being infused during this period was 74.609ml.The infusion ran for 38 hours and 7 minutes during this period however the device was not infusing for approximately 1 hour due to delay programming or patient side occlusion alarm.Third: the third instance started at 2:17 am on (b)(6) 2019 when the user changed the vtbi of the bumetanide continuous 25mg/100ml (drugid 61) infusion running at 2ml/hr to 100ml.The infusion ran until 9:12 pm on (b)(6) 2019 when the user changed the vtbi to 90ml.The volume recorded as being infused during this period was 84.849ml.The infusion ran for 42 hours and 55 minutes during this period however the device was not infusing for approximately 28 minutes and 36 seconds due to delay programming or patient side occlusion alarms.During this period, the device was not infusing for approximately 28 minutes and 36 seconds due to delay programming or patient side occlusion alarms.Fourth: the fourth instance started at 9:12 pm on (b)(6) 2019 when the user changed the vtbi of the bumetanide continuous 25mg/100ml (drugid 61) infusion running at 2ml/hr to 90ml.The rates were changed as reported at 9:58 am on (b)(6) 2019 to 3ml/hr (dose = 0.75mg/hr) and ran at 3ml/hr until 10:38 am to 4ml/hr (dose = 1mg/hr).The infusion ran at 4ml/hr until 11:44 am on (b)(6) 2019 when the device was channeled off and not at 9:45 am on (b)(6) 2019 as was reported.There were no alarms prior to the user channeling the device off.The customer did not allege an overinfusion for this instance since the infusion ran at different rates.There were no alarms prior to the user channeling the device off.The root cause of the customer¿s report of infusing faster than expected was not identified.No device was returned for investigation.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9335826
• MDR Text Key: 166805117
• Report Number: 2016493-2019-01454
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8100
• Device Catalogue Number: 8100
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2)PRI TUBING,8015,8100, TD (B)(6) 2019.; 8100.; (2)PRI TUBING,8015,8100, TD 10/5/19
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 153