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

Model Number 8100

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Underdose (2542)

Event Date 01/25/2021

Event Type  Injury  

Manufacturer Narrative

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.Although requested, no patient information provided.

Event Description

It was reported the pump was not delivering any levophed.The intended programming was 16mg in 250ml normal saline with a continuous infusion rate between 0.2 mcg(microgram)/kg/min and 0.5 mcg/kg min titrated to a mean arterial pressure (map) of greater than 60.The nurse kept titrating the levophed up, with no noticeable change in the patient's blood pressure.Levophed was disconnected and there was no difference in patient's blood pressure noted.The line was primed and loaded correctly but it gave no errors.Upon further inspection the tubing inside the channel was flat and the internal pump mechanism did not seem to be working correctly while the pump seemed to be infusing with no problems or errors/alarms.The charge rn, resident, and fellow were notified.A second pressor was started due to this event.The set of tubing was dated and hung on january 22nd and the bottle of levophed had more than 250ml of volume in it where a new bottle has 250ml.This event occurred in the micu.No patient harm.Although requested, no further information provided.

Event Description

It was reported the pump was not delivering any levophed.The intended programming was 16mg in 250ml normal saline with a continuous infusion rate between 0.2 mcg(microgram)/kg/min and 0.5 mcg/kg min titrated to a mean arterial pressure (map) of greater than 60.The nurse kept titrating the levophed up, with no noticeable change in the patient's blood pressure.Levophed was disconnected and there was no difference in patient's blood pressure noted.The line was primed and loaded correctly but it gave no errors.Upon further inspection the tubing inside the channel was flat and the internal pump mechanism did not seem to be working correctly while the pump seemed to be infusing with no problems or errors/alarms.The charge rn, resident, and fellow were notified.A second pressor was started due to this event.The set of tubing was dated and hung on january 22nd and the bottle of levophed had more than 250ml of volume in it where a new bottle has 250ml.This event occurred in the medical intensive care unit (micu).No patient harm.

Event Description

It was reported the pump was not delivering any levophed.The intended programming was 16mg in 250ml normal saline with a continuous infusion rate between 0.2 mcg(microgram)/kg/min and 0.5 mcg/kg min titrated to a mean arterial pressure (map) of greater than 60.The nurse kept titrating the levophed up, with no noticeable change in the patient's blood pressure.Levophed was disconnected and there was no difference in patient's blood pressure noted.The line was primed and loaded correctly but it gave no errors.Upon further inspection the tubing inside the channel was flat and the internal pump mechanism did not seem to be working correctly while the pump seemed to be infusing with no problems or errors/alarms.The charge rn, resident, and fellow were notified.A second pressor was started due to this event.The set of tubing was dated and hung on (b)(6) and the bottle of levophed had more than 250ml of volume in it where a new bottle has 250ml.This event occurred in the medical intensive care unit (micu).No patient harm.

Manufacturer Narrative

The customer¿s complaint of an under infusion was not reproduced.However, inspection of the returned administration set showed the silicone segment was fused at the approximate location of the occluder fingers.Inspection: the device was received in fair condition.The instrument seal was intact.Dried fluid was observed on both iui¿s and on the rear case under the male iui.Corrosion was observed on the male iui, inside the rear case, and on bezel frame.Platen assembly, post, hinge, pins, springs, and buttons are all intact and did not interfere with the door operation.Latch sear are installed properly and did not interfere with the door operation.All parts inspected are manufactured by bd.Bezel was observed in good condition.The returned used administration set (model 2420-0007; lot: unknown) was received in poor condition.The returned administration set was visually inspected for incomplete bonding engagements, holes/tears in the tubing or damages to the components.The silicone segment was observed twisted with two locations pinched closed.The locations that were pinched closed were manipulated by hand to re-open.Log analysis results: review of the suspect device error log showed no errors were recorded on the reported event date.The customer provided an event date of (b)(6) 2021 at 8:40 pm.Review of the suspect device event log showed, prior to the reported event date, the suspect device was powered on attached to pcu sn (b)(6) as channel b at 11:18 pm on (b)(6) 2021.The suspect device successfully completed multiple infusions between (b)(6) 2021 and (b)(6) 2021.On (b)(6) 2021 at 12:16 pm, the suspect device was selected and programmed an infusion of an unknown medication at a rate of 1.785 ml/hr.Between 1:59 pm and 8:40 pm, the suspect device was selected and programming parameters were changed multiple times, resulting in changes to the rate.Between 8:50 pm and 8:55 pm, the suspect device alarmed for: door opened (4 times); flo stop open (4 times totaling 11 seconds); check iv set (1 time); the device was not in use after 8:55 pm on (b)(6) 2021.Root cause: the probable cause of the customer¿s complaint of an under infusion was believed to be due to the silicone segment of the administration set being fused closed.Prior investigations have found that when the tubing is fused together between the two occluder fingers, the device may not be able to detect an occlusion condition in the set.Device history review: a review of the device history record showed the device had a manufacture date of 02/27/2018.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record for source device lvp sn (b)(6) 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 the source device lvp sn (b)(6) which did not confirm similar complaints with the same or related failure mode for this customer.H3 other text: device received with completed investigation.

• Brand Name: ALARIS PUMP MODULE
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 11301095
• MDR Text Key: 239766978
• Report Number: 2016493-2021-22522
• 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: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2021
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2939-2020
• Patient Sequence Number: 1
• Treatment: PRI TUBING,8015, TD (B)(6) 2021; PRI TUBING, 8015, TD (B)(6) 2021
• Patient Outcome(s): Required Intervention