MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number PRI TUBING

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems Missed Dose (2561); No Information (3190)

Event Date 02/13/2019

Event Type  malfunction  

Manufacturer Narrative

Stroke.(b)(4).The customer¿s report of an underinfusion was not confirmed.The pcu event log shows pump module s/n (b)(4) was programmed to infuse a custom concentration infusion of alteplase cva 100kg or less (drugid (b)(6)) at a rate of 59ml/hr with a vtbi of 45ml at 9:19 pm on (b)(6) 2019 and completed at 10:07 pm.The volume recorded as being infused during this period was 53.352ml.Although requested, no product was received for investigation.The starting/ending volume of the fluid container cannot be determined through device logs.The disposable set was also listed as a suspect device, however since the set was not returned, a determination whether or not the set contributed to the underinfusion could not be made.The root cause of the reported underinfusion was not identified.Device evaluated by mfr: log review only.

Event Description

It was reported that a stroke patient missed the entire remaining dose of tpa (tissue plasminogen activator 0.81mg/kg/hr/1mg/1ml) medication in the time allotted to receive the drug in the ed.The patient received an initial bolus dose 6.5 mg by the pharmacist, and was to be followed by a tpa (1mg/1ml) 59ml/hr.Infusion for 1hr.From 2121-2221.At 2221 the user noticed a vtbi of zero; there was 59ml fluid remaining in the vial and the ed pharmacists were alerted.At 2230, the neurology resident was notified and did not wish to restart the remaining tpa infusion due to the patient exceeded the ¿window of time frame¿ of 5 hours required to receive additional treatment.When the remaining fluid in the iv bag was hung to gravity and the fluid emptied from the tubing, it was discovered that the entire infusion (59 ml) remained in the vial/tubing and therefore the patient did not receive any of the remaining tpa infusion after the initial bolus was given.The customer indicated that there was no patient harm however they stated that they were unable to determine at this time whether missing the medication would have a deleterious effect.A third party service department tested the devices and found no fault.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "event also reported as an equipment event: capturing dose omission of tpa in this report for medication event review.A (b)(6) female presented to the ed as stroke alert red.Pt was deemed candidate for tpa therapy.Tpa was prepared by pharmacy.Bolus dose of 6.5 mg was given over 1 min at 2120 by pharmacist on call.Upon initiation of tpa infusion, pump was programmed by ed pharmacist and double- checked by pharmacist on call for accuracy.There were no alarms wounding throughout the time that tpa should have been infusing (from 2121-2221).At the one hour mark (2221), the pump alarmed and the vtbi read zero; however, the rn noticed there was still a lot of fluid in the vial and alerted the ed pharmacists.The info programmed in the pump was still reviewed and was correct including the amount that should've been infused, infusion rate, and put weight.Pharmacy called neurology resident to let him know there had been a pump malfunction and to ask if the neurology attending wanted the remaining tpa to be infused on a new pump.At this time (-2230), pt was out of the window to receive tpa (at 5 hour mark at this point) and neurology attending did not wish to restart the tpa infusion.The vial was taken down by pharmacy.The vial tubing, and pump were further inspected by two ed pharmacists and myself.(b)(6) has pictures of the pump info entered correctly on her phone and the tagged pump is being kept in the ed pharmacist office for further inspection.To determine how much tpa was infused, the remaining volume was pulled from tubing and vial.When (b)(6) attached a syringe to the tubing, she was unable to pull any fluid from the line even though the vent was open.There were no kinks, and the roller clamp was open.When the vial i tubing were hung to gravity.All of the fluid came out.Unfortunately, the amount of drug remaining was the entire infusion (59mg or 59 ml) and therefore pt did not receive any of the tpa infusion.I have edited the scm note and marked the medication as not given on the mar (of note, pt did receive the bolus dose given at 2120).Presented to (b)(6) on (b)(6) 2019 as a stroke alert for lower extremity weakness.The pt stated that she was last known to be normal arounds 1730 on (b)(6) 2019 when she had the sudden onset of inability to ambulate.Fda safety report id# (b)(4).".

Event Description

It was reported that a stroke patient missed the entire remaining dose of tpa (tissue plasminogen activator 0.81mg/kg/hr/1mg/1ml) medication in the time allotted to receive the drug in the ed.The patient received an initial bolus dose 6.5 mg by the pharmacist, and was to be followed by a tpa (1mg/1ml) 59ml/hr.Infusion for 1hr.From 2121-2221.At 2221 the user noticed a vtbi of zero; there was 59ml fluid remaining in the vial and the ed pharmacists were alerted.At 2230, the neurology resident was notified and did not wish to restart the remaining tpa infusion due to the patient exceeded the ¿window of time frame¿ of 5 hours required to receive additional treatment.When the remaining fluid in the iv bag was hung to gravity and the fluid emptied from the tubing, it was discovered that the entire infusion (59 ml) remained in the vial/tubing and therefore the patient did not receive any of the remaining tpa infusion after the bolus was initially given as intended.The customer indicated that there was no patient harm however they stated that they were unable to determine at this time whether missing the medication will have a deleterious effect.A third party service department tested the devices and found no fault.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "event also reported as an equipment event: capturing dose omission of tpa in this report for medication event review.A (b)(6) y/0 female presented to the ed as stroke alert red.Pt was deemed candidate for tpa therapy.Tpa was prepared by pharmacy.Bolus dose of 6.5 mg was given over 1 min at 2120 by pharmacist on call.Upon initiation of tpa infusion, pump was programmed by ed pharmacist and double- checked by pharmacist on call for accuracy.There were no alarms wounding throughout the time that tpa should have been infusing (from 2121-2221).At the one hour mark (2221), the pump alarmed and the vtbi read zero; however, the rn noticed there was still a lot of fluid in the vial and alerted the ed pharmacists.The info programmed in the pump was still reviewed and was correct including the amount that should've been infused, infusion rate, and put weight.Pharmacy called neurology resident to let him know there had been a pump malfunction and to ask if the neurology attending wanted the remaining tpa to be infused on a new pump.At this time (-2230), pt was out of the window to receive tpa (at 5 hour mark at this point) and neurology attending did not wish to restart the tpa infusion.The vial was taken down by pharmacy.The vial tubing, and pump were further inspected by two ed pharmacists and myself.(b)(6) has pictures of the pump info entered correctly on her phone and the tagged pump is being kept in the ed pharmacist office for further inspection.To determine how much tpa was infused, the remaining volume was pulled from tubing and vial.When (b)(6) attached a syringe to the tubing, she was unable to pull any fluid from the line even though the vent was open.There were no kinks, and the roller clamp was open.When the vial i tubing were hung to gravity.All of the fluid came out.Unfortunately, the amount of drug remaining was the entire infusion (59mg or 59 ml) and therefore pt did not receive any of the tpa infusion.I have edited the scm note and marked the medication as not given on the mar (of note, pt did receive the bolus dose given at 2120).Presented to (b)(6) on (b)(6) 2019 as a stroke alert for lower extremity weakness.The pt stated that she was last known to be normal arounds 1730 on (b)(6) 2019 when she had the sudden onset of inability to ambulate.Fda safety report id# (b)(4).".

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8664831
• MDR Text Key: 147036101
• Report Number: 9616066-2019-01405
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015, 8100, TPA BOTTLE, SYRINGE, (B)(6) 2019
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR
• Patient Weight: 73