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

Model Number 2420-0007

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Therapeutic Response, Increased (2272)

Event Date 03/10/2019

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

It was reported that on an adult general care unit, a patient¿s infusion of heparin (2500 units/250 ml) was expected to infuse at 11 ml/hr and the bag was found empty earlier than expected at 1500.The vtbi was programmed from the previous shift, and the vi at the time of the event was unspecified.The heparin bag was changed in the morning, and was expected to continue to the following night shift (unspecified time).An ail alarm occurred earlier in the day and approximately 30 ml of volume was discarded during troubleshooting of the alarm.The nurse then manually counted the drip rate and noticed that pump appeared to be infusing faster than the programmed rate.The nurse removed the set from the module and inserted it into a different module.The drip rate still appeared to be faster than the programmed rate.The nurse obtained a new pump, and the set was installed into the new pump.The drip rate continued to appear to be faster than the programmed rate.The set was then changed which appeared to correct the infusion rate.After the event, the heparin was stopped for 60 minutes and the rate was decreased.A stat partial thromboplastin time (ptt) was ordered.At 19:00, value was greater than 140.At 7 am before the incident, the ptt was 94.Prior to the heparin infusion the patient received magnesium and thiamine.No other medications were infusing via the same pc unit at the time of the event.The event set was sequestered, the devices were not.No other effect to the patient was reported.Received a copy of the customer's (b)(6) program report from (b)(6) which states, ¿patient being treated for atrial fibrillation.Heparin infusion was running at 11ml/hr.Nurse calculated how many hours the heparin bag would last at the beginning of their shift.The bag was expected to last until the following night shift: however, the bag was found to be empty around 1500 hrs.

Event Description

It was reported that on an adult general care unit, a patient¿s infusion of heparin (2500 units/250 ml) was expected to infuse at 11 ml/hr and the bag was found empty earlier than expected at 1500.The vtbi was programmed from the previous shift, and the vi at the time of the event was unspecified.The heparin bag was changed in the morning, and was expected to continue to the following night shift (unspecified time).An ail alarm occurred earlier in the day and approximately 30 ml of volume was discarded during troubleshooting of the alarm.The nurse then manually counted the drip rate and noticed that pump appeared to be infusing faster than the programmed rate.The nurse removed the set from the module and inserted it into a different module.The drip rate still appeared to be faster than the programmed rate.The nurse obtained a new pump, and the set was installed into the new pump.The drip rate continued to appear to be faster than the programmed rate.The set was then changed which appeared to correct the infusion rate.After the event, the heparin was stopped for 60 minutes and the rate was decreased.A stat partial thromboplastin time (ptt) was ordered.At 19:00, value was greater than 140.At 7 am before the incident, the ptt was 94.Prior to the heparin infusion the patient received magnesium and thiamine.No other medications were infusing via the same pc unit at the time of the event.The event set was sequestered, the devices were not.No other effect to the patient was reported.Received a copy of the customer's cmdsnet program report from health canada which states, ¿patient being treated for atrial fibrillation.Heparin infusion was running at 11ml/hr.Nurse calculated how many hours the heparin bag would last at the beginning of their shift.The bag was expected to last until the following night shift: however, the bag was found to be empty around 1500 hrs.Nurse discussed the situation with a colleague who dealt with an air-in-line alarm on the pump.The nurse's colleague stated that she discarded a bit of heparin to remove the air but the volume discarded was no more than 30 ml.This volume was not great enough to account for the missing volume in the bag.The nurse then manually counted the drip rate and noticed that pump appeared to infusing faster than the programmed rate.The nurse removed the set from them module and inserted into a different module.The drip rate still appeared to be faster than the programmed rate.A completely new pump was grabbed and the set was installed into the new pump.Still, the drip rate appeared to be faster than the programmed rate.The set was then changed which appeared to correct the infusion rate.".

Manufacturer Narrative

The customer report of a patient¿s infusion bag was found empty earlier than expected was not confirmed or replicated during laboratory testing.Visual inspection showed no anomalies or leaks.Functional testing identified no anomalies.A timed rate accuracy test was performed with a test pump module; the set passed rate accuracy.After testing was completed, a dimensional analysis was performed on the silicone segment.Measurement analysis of the iv set confirmed that the set had significantly more variation in wall thickness creating an eccentric or non-concentric shape in the wall of the silicone pumping segment between its inside diameter (id) and outside diameter (od), which can contribute to a failure to fully occlude the line.The root cause of the customer's report could not be definitively identified.

• 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: 8485785
• MDR Text Key: 141014671
• Report Number: 9616066-2019-00878
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012591
• UDI-Public: 7613203012591
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRI TUBING,8100,(2)8015,8100, TD (B)(6) 2019; PRI TUBING,8100,(2)8015,8100, TD (B)(6) 2019
• Patient Outcome(s): Required Intervention