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U.S. Department of Health and Human Services

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

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CAREFUSION SD ALARIS PUMP MODULE; PUMP, INFUSION Back to Search Results
Model Number 8100
Device Problems Insufficient Flow or Under Infusion (2182); No Audible Prompt/Feedback (2282)
Patient Problems High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Respiratory Failure (2484)
Event Date 03/19/2021
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted once the evaluation is completed.Diagnosis- acute respiratory failure with hypoxemia.Evaluation pending.
 
Event Description
It was reported that after several hours of a norepinephrine infusion being run, the bag remained full.The rate was 63 ml/hour with a 250 ml bag, therefore the bag should have required replacement every 4 hours.Upon investigation, the tubing inside the channel was sealed together in two areas obstructing flow.During administration the pump was not alarming for occlusion, or empty container.Patient required administration of additional, new drug, vasopressin, for blood pressure support and to stabilize patient's blood pressure, while the tubing was not functioning correctly.The patient remained in icu, ultimately no effect once error was detected.As stated by customer.No further information is available.
 
Event Description
It was reported that after several hours of a norepinephrine infusion being run, the bag remained full.The rate was 63 ml/hour with a 250 ml bag, therefore the bag should have required replacement every 4 hours.Upon investigation, the tubing inside the channel was sealed together in two areas obstructing flow.During administration the pump was not alarming for occlusion, or empty container.Patient required administration of additional, new drug, vasopressin, for blood pressure support and to stabilize patient's blood pressure, while the tubing was not functioning correctly.The patient remained in icu, ultimately no effect once error was detected.As stated by customer.No further information is available.
 
Manufacturer Narrative
The complaint of an under infusion was not reproduced.The complaint of failure to alarm occlusion was also not reproduced.Inspection lvp sn (b)(6).The device was received in fair condition.The instrument seal was peeled up.Dried fluid was observed on the male iui, on the rear case under the female iui, and inside the rear case dried fluid and corrosion were observed on the female iui.Damage observed on the lighthouse.Crush marks observed at the upper fitment of the tube guide which is indicative of a set misload.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.Iui bracket was observed with a broken plastic tab; the broken piece was not recovered during disassembly bezel was disassembled and observed in fair condition.The event administration set was not returned for investigation.However, the provided picture showed the set was partially fused at two locations.This could be a contributing factor, however since it was not returned it could not be tested.Review of the pcu error log showed no errors were recorded on the reported event date.Review of the pcu event log showed the suspect device successfully completed multiple infusions of guardrail drug norepinephrine (8mg/250 ml; drugid=473) at multiple rates.No alarms were recorded.Volume infused= 811.49 ml.Inspection of the device showed the pressure sensors were in good condition.Testing showed the pressure sensors performed within specification.Testing showed the device was delivering fluids within specification.Root cause analysis: the root cause of the complaint of an under infusion was not identified.The root cause of the complaint of failure to alarm occlusion was not identified.Device history review: lvp sn (b)(6).A review of the device history record showed the device had a manufacture date of 04/14/2015.The review was performed from the date of manufacture to the date of product release for distribution.A review of the device history record in sap 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 in trackwise and sap 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.
 
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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 Key11689294
MDR Text Key246738600
Report Number2016493-2021-502709
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 03/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number8100
Device Catalogue Number8100
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/05/2021
Initial Date Manufacturer Received 03/24/2021
Initial Date FDA Received04/19/2021
Supplement Dates Manufacturer Received04/28/2021
Supplement Dates FDA Received05/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8015; 8100; 8100; 8100; PRI TUBING
Patient Outcome(s) Required Intervention;
Patient Age65 YR
Patient Weight69
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