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

Model Number 8015

Device Problems Defective Alarm (1014); Premature Discharge of Battery (1057); Battery Problem (2885)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 11/24/2020

Event Type  Death  

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 further event or patient information was provided.

Event Description

It was reported that the pump did not alarm and unexpectedly powered down when transferring the patient from emergency center to icu.While in the elevator, the iv pump infusing fluids and high dose vasopressors stopped infusing and shut down due to low battery error.The infusions were switched to gravity by staff at that time.Once the pump was plugged in, it was functioning normally again.Upon arrival on the unit the patient lost pulse and a code blue was initiated.Return of spontaneous circulation (rosc) was not achieved, and the patient expired.It was later clarified by the biomed supervisor that the devices will not be returned to bd for investigation, as there was no device malfunction and the event had been reported incorrectly.According to an unspecified patient safety officer in charge of this case, the information initially provided was inaccurate, because multiple people were adding input and there was confusion obtaining accurate information.The pump never shut off and never stopped infusing during transport, or at any time.This was reported in error.The infusions were never switched to gravity, as the pump did not malfunction or stop.The pump did alarm for low battery, and the physician who was present during patient transport saw the low battery alarm displayed on the screen, while infusions continued as programmed throughout the whole process.It is unknown how long the pump was not plugged in prior to and during transport.The device serial numbers were discovered through interoperability investigation of the drug infusion and patient id, however when requested the device serial numbers were not clarified.The customer's biomed investigation showed the battery still held a charge, however needed to be replaced after reconditioning.This was normal device maintenance, not a malfunction.It was determined by the customer's investigation that there was no device malfunction, and this event did not cause or contribute to the patient¿s death.Although requested, no further event or patient information was provided.

• Brand Name: ALARIS PC UNIT
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 11114309
• MDR Text Key: 224984426
• Report Number: 2016493-2020-85404
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 10885403801518
• UDI-Public: 10885403801518
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: (2)PRI TUBING,(2)8100, TD (B)(6) 2020
• Patient Outcome(s): Death