Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SD ALARIS SYSTEM PC UNIT; PUMP, INFUSION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION SD ALARIS SYSTEM PC UNIT; PUMP, INFUSION Back to Search Results
Model Number 8015
Device Problems Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)
Patient Problem Premature Labor (2465)
Event Date 12/22/2020
Event Type  Injury  
Manufacturer Narrative
(b)(6).Although requested, the affected device has not been received.A follow up report will be submitted with investigation results should the device be received for evaluation.Race and ethnicity: caucasian.Admitting diagnosis: labor.
 
Event Description
It was reported that one of the large volume pump (lvp) was scanned to deliver a bolus but both of the lvps delivered a bolus.Channel a was infusing lactated ringers iv solution and channel b was infusing pitocin.Due to the event, the patient received a significant dose of pitocin that caused the uterus to clamp down and prevented oxygenated blood from the uterus to the baby.The conservative measures that were taken: maternal position change, iv fluid bolus, medications to counteract the pitocin and when all efforts failed the patient had an emergency cesarean section to remove the baby.The mother and baby were discharged on (b)(6) 2020.This report (b)(6) is for the mother while (b)(6) is for the baby.
 
Event Description
It was reported that one of the large volume pump (lvp) was scanned to deliver a bolus but both of the lvps delivered a bolus.Channel a was infusing lactated ringers iv solution and channel b was infusing pitocin.Due to the event, the patient received a significant dose of pitocin that caused the uterus to clamp down and prevented oxygenated blood from the uterus to the baby.The conservative measures that were taken: maternal position change, iv fluid bolus, medications to counteract the pitocin and when all efforts failed the patient had an emergency cesarean section to remove the baby.The mother and baby were discharged on (b)(6) 2020.This report (b)(6) is for the mother while (b)(6) is for the baby.
 
Manufacturer Narrative
Correction: d1 (brand name), d4 (model #), d4 (catalog #), d4 (serial #), d4 (udi #), h4 additional information: a6, b7, d9, d10 investigation conclusion: the report of the patient receiving a significant dose of pitocin was not definitively confirmed in the logs or replicated during testing.The pcu error log found no errors or malfunctions on the incident date.The pcu event log confirmed the medication lactated ringers was being infused on ¿channel a¿ and the medication pitocin infusing on ¿channel b¿ on the reported incident date.The logs record the pitocin infusion is terminated when the device is channeled off.The logs show channel b (pump module s/n (b)(6)) receives a ¿remote iv¿ message for the medication lr bolus (drug id 426) and is to infuse at a rate of 999ml/hr vtbi 1000ml.The vtbi is changed by the user.The user then starts the infusion.The logs could not confirm if the iv bag containing pitocin was changed at the time the ¿remote iv¿ message was received, and infusion started by the user.Testing identified the medications being infused on the source pump module.Rate accuracy testing performed on the source pump modules found the device delivering fluids in specifications.Device inspection: pump module s/n (b)(6) was received with instrument seal intact.The right (male) iui was observed with corrosion, damaged isolation ribs, and dry fluid residue.The left (female) iui was observed to be in good condition.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.Pump module s/n (b)(6) was received with instrument seal missing.The right (male) iui was observed with corrosion and dry fluid residue.The left (female) iui was observed to be in good condition.Platen assembly, post, hinge, springs, and buttons are all intact and did not interfere with the door operation.The lower platen retainer pin was observed missing.Latch sear are installed properly and did not interfere with the door operation.All parts inspected are manufactured by bd.The incident administration set was not returned and could not be inspected.Timed rate accuracy test performed on both pump modules found the devices to be within specification.Root cause analysis: the probable cause of the patient receiving a significant dose of pitocin is likely to be the result of programming.The logs recorded the user channeling off the oxytocin (pitocin) infusion.Approximately one minute later pcu receives a ¿remote iv¿ message for pump module s/n (b)(6).The message contained infusion parameters for lr bolus (drug id 426) which is programmed to infuse at a rate of 999ml/hr.The logs could not determine if the pitocin iv bag and administration set was removed and lr bolus was loaded.It also could not be determined if the message for the lr bolus was meant for pump module s/n (b)(6) (channel a) which was also infusing lactated ringers and manually programmed at a rate of 999ml/hr.Device history review: review of the source pcu s/n (b)(6) service history record showed the device had a manufacture date of 23jul2016.A review of the device service history record was performed beginning from the date of manufacture to the present date 24feb2021 and indicated that this device has been previously returned for service issues unrelated to the reported complaint.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.The review of complaint history records in was performed for the returned source devices ((b)(6)) which did not confirm similar complaints with the same or related failure mode for this customer.H3 other text : device received for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ALARIS SYSTEM PC UNIT
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
CAREFUSION SD
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key11169673
MDR Text Key226782950
Report Number2016493-2021-09611
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10885403810015
UDI-Public10885403810015
Combination Product (y/n)N
PMA/PMN Number
K133532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8015
Device Catalogue Number8015
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/13/2021
Date Manufacturer Received02/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
(2)PRI TUBING,8015,THERAPY DATE 12/22/2020; 8100; (2) PRI TUBING, 8015, THERAPY DATE (B)(6) 2020
Patient Outcome(s) Required Intervention;
Patient Age32 YR
Patient Weight93
-
-