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

Model Number 8015

Device Problem Unexpected Shutdown (4019)

Patient Problems Hypovolemia (2243); Blood Loss (2597)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

The device has been received and an evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported that there were two point of care units (pcus) that shut off during infusion of multiple pressors and inotropes.Each pcu had 4 large volume pumps (lvps) attached.The patient arrived to cticu after ventricular assist device (vad) implant and became acutely unstable with copious amounts of frank red blood draining from chest tube.Massive transfusion protocol called with moderately successful resuscitative efforts.At one point, the patient became profoundly unstable and vlad began to suction alarm.It was noted at that time that the iv pumps had shut off for no apparent reason.The result was, the patient received multiple pushes of code dose epinephrine by the team attending and emergent changes to vad flows.This was reported to be a life-threatening adverse effect to the patient.The users reported that both pcus were off and neither had alarmed prior to somehow turning off.The batteries were fairly charged when retrieved and both had an estimated runtime of 4 hours.The event logs were downloaded from the maintenance software but it could not be determined if there were any interruptions during infusion.

Manufacturer Narrative

The customer¿s stated issue of two pcus shutting off during infusions was confirmed on one of the returned systems through a review of the device logs and through testing.The log review identified 8 channel disconnects on (b)(6) 2020 throughout the day on pcu (b)(6).The last two events occurred at 3:20:04 pm and 5:30:34 pm where alarms were exhibited.No channel disconnects were found on pcu sn: (b)(6) on (b)(6) 2020.Functional testing consisting of iui testing performed on the source pcu¿s found pcu sn: (b)(6) operating in specification.However, pcu sn: (b)(6) failed, exhibiting a channel disconnect during testing.The pcu sn: (b)(6) has a female iui with a date code of 11/2015.Indicating the iui is nearly 5 years old.There was fibrous material stuck on top of some of the contact pins within the housing.The pcu sn: (b)(6) has a female iui with a date code of 04/2007.Indicating the iui is approximately 13 years old.Proper iui connector inspection and cleaning practices should be followed as instructed by the alaris user manual.Iui connectors should be inspected prior to use and should be replaced when surface contaminants, blue or green corrosion or cracks are identified.Iui covers are available to protect from contamination which can lead to corrosion.Both pcu¿s were found to have a third-party power cords installed.Customer¿s use of replacement parts that have not been approved by bd for the alaris system is at the customer¿s own risk and patient risk, and may void the product warranty provided by bd.If non-bd parts are used for the maintenance, repair or operation of your bd equipment, those parts have not been validated by bd to be used within the alaris system medical devices.Inspection: pcu sn: 14526640 an internal and external inspection were performed on the source device.There were no observations of fluid ingress in the front cover or rear case.There was no contamination observed on the electronic components.The female iui has a date code of 11/2015.Pcu sn: (b)(6).An internal and external inspection were performed on the source device.There were observations of fluid ingress on both the bottoms of the front cover and rear case.There was slight contamination observed on the lower right side of the logic board.The female iui has a date code of 04/2007, image 6 shows the extent of the crack in the iui.The female iui has a date code of 04/2007 and it is cracked at the top right corner.The proximate cause of the customer¿s complaint where two systems shut off during infusions was only identified on pcu sn: 12535542, attributed due to a broken female iui.The root cause of the system pcu sn: 14526640 shutting off was not definitively determined.Testing confirmed this system is operating as intended.Device history review: review of the sn: (b)(6) service history record showed the device had a manufacture date of 07dec2015.A review of the device service history record was performed beginning from the date of manufacture to the present date 29sep2020 and indicated that this device has not been previously returned for service.Review of the production failure record was performed beginning from the date of manufacture through present.The failure record showed no production failure records were opened for the source device.Review of the sn: (b)(6) service history record showed the device had a manufacture date of 29apr2007.A review of the device service history record was performed beginning from the date of manufacture to the present date 29sep2020 and indicated that this device has not been previously returned for service.Review of the production failure record was performed beginning from the date of manufacture through present.The failure record showed no production failure records were opened for the source device.

Event Description

It was reported that there were two point of care units (pcus) that shut off during infusion of multiple pressors and inotropes.Each pcu had 4 large volume pumps (lvps) attached.The patient arrived to cardio thoracic intensive care unit (cticu) after ventricular assist device (vad) implant and became acutely unstable with copious amounts of frank red blood draining from ct.Massive transfusion protocol (mtp) called with moderately successful resuscitative efforts.At one point, the patient became profoundly unstable and ventricular left assist device (vlad) began to suction alarm.It was noted at that time that the iv pumps had shut off for no apparent reason.The result was, the patient received multiple pushes of code dose epinephrine by the team attending and emergent changes to vad flows.This was reported to be a life-threatening adverse effect to the patient.The users reported that both pcus were off and neither had alarmed prior to somehow turning off.The batteries were fairly charged when retrieved and both had an estimated runtime of 4 hours.The event logs were downloaded from the maintenance software but it could not be determined if there were any interruptions during infusion.

• Brand Name: ALARIS PC UNIT
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10595652
• MDR Text Key: 208833802
• Report Number: 2016493-2020-11812
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801518
• UDI-Public: 10885403801518
• Combination Product (y/n): N
• PMA/PMN Number: K091308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (7)8100,(7)PRI TUBING; 8100,PRI TUBING, TD (B)(6) 2020; 8100, PRI TUBING, TD (B)(6) 2020
• Patient Outcome(s): Life Threatening