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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION ALARIS EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 20350E
Device Problems Backflow (1064); Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); Underdose (2542)
Event Date 03/31/2020
Event Type  malfunction  
Manufacturer Narrative
Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.
 
Event Description
It was reported that tubing leaked/splashed.Prior to observing the leak, the nurse observed fluid on the bedding and patient's clothes and believed it was a result of incontinence.The patient's clothes and bedding were changed.Fluid was also noted on the floor and cleaned by the nurse in her chemotherapy gown, gloves and surgical mask.Later, during an administration of paclitaxel, blood was seen back flowing into the filter.The fluid was "spirting" from the connection point of a primary tubing and extension set.The paclitaxel infusion was attached via secondary tubing to the primary line.Dextrose 5% in water was infusing in the primary line.There was no patient harm.The patient did not receive the dose of paclitaxel; however, it was noted this was not expected to cause significant impact on the disease progression.It was reported that no visible crack or other deformities were visible.Although requested, no additional patient information was provided.
 
Event Description
It was reported that the tubing leaked and/or splashed.Prior to observing the leak, the nurse observed fluid on the bedding and the patient's clothes and believed it was a result of incontinence.The patient's clothes and bedding were changed.Fluid was also noted on the floor and cleaned by the nurse in her chemotherapy gown, gloves and surgical mask.Later, during an administration of paclitaxel, blood was seen back flowing into the filter.The fluid was "spirting" from the luer lock connection of the filter extension set.This extension set was attached to a primary line while the paclitaxel infusion was attached via secondary tubing to the primary line.Dextrose 5% in water was infusing in the primary line.There was no patient harm.The patient did not receive the dose of paclitaxel; however, it was noted this was not expected to cause significant impact on the disease progression.It was reported that no visible crack or other deformities were visible.It was confirmed during follow up that there was no delay in patient care, and that this event did not contribute to, or result in a serious adverse impact to patient.
 
Manufacturer Narrative
The customer's report that fluid was squirting out from the luer lock connection of the filter extension set was confirmed based on the customer provided video.The video shows fluid squirting out from the set's female luer lock component.However, no set samples or devices were received for evaluation.The root cause was not identified.The device history record for model 20350e lot 19117133 shows the set was manufactured on (b)(6) 2019 with a total of 6,603 units.There were no quality notifications issued during the production build of this set.
 
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Brand Name
ALARIS EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9986276
MDR Text Key193617273
Report Number9616066-2020-01376
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012256
UDI-Public7613203012256
Combination Product (y/n)N
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/29/2022
Device Model Number20350E
Device Catalogue Number20350E
Device Lot Number19117133
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/22/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/19/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SEC TUBING, PRI TUBING, 8100, 8015,TD: (B)(6) 2020.
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