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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 10011865
Device Problems Fluid Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: ng suction tube, suction machine, 3 way y-connector, microtubing; picc line - 26 gauge/lot 12215869, cut to 25 cm and secured at 25 cm. Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
The customer reported a leak from a hole in female luer of the filter extension set when infusing tpn programmed at 13 ml/ hr. When attached to the patients picc line. It was reported that the set was flushed and confirmed fluid leaking out "sideways" from the female luer, there was no cracks noted. The set was in use for 2 days when the leak occurred. Other infusion at the time of the event were lipids 0. 7 ml/hr. , vancomycin at an unspecified rate and normal saline (used for ngr, ng replacement) and gentamycin however not infusing. There was no report of patient harm.
 
Manufacturer Narrative
Concomitant medical products: 3ml syringe, lot number 803911c, exp 2021-02-07, normal saline. The affected product has been received and the evaluation is pending. A follow up report will be submitted once the evaluation is completed.
 
Event Description
The customer reported a leak from a hole/crack in female luer of the "nvn filter" neonatal venous nutrition extension set when infusing tpn programmed at 13 ml/hr. When attached to the patients picc line. It was reported that the set was flushed and confirmed fluid leaking out "sideways" from the female luer. The set was in use for 2 days when the leak occurred. Other infusion at the time of the event were lipids 0. 7ml/hr. , vancomycin at an unspecified rate and normal saline (used for ngr, ng replacement) and gentamycin however not infusing. There was no report of patient harm.
 
Manufacturer Narrative
Concomitant medical products: 3ml syringe, lot number 803911c, exp 2021-02-07, normal saline. The affected product has been received and the evaluation is pending. A follow up report will be submitted once the evaluation is completed.
 
Event Description
The customer reported a leak from a hole/crack in female luer of the "nvn filter" neonatal venous nutrition extension set when infusing tpn programmed at 13 ml/hr. When attached to the patients picc line. It was reported that the set was flushed and confirmed fluid leaking out "sideways" from the female luer. The set was in use for 2 days when the leak occurred. Other infusion at the time of the event were lipids 0. 7ml/hr. , vancomycin at an unspecified rate and normal saline (used for ngr, ng replacement) and gentamycin however not infusing. There was no report of patient harm.
 
Manufacturer Narrative
The customer¿s report of a leak from a hole/crack in the female luer of the filter extension set was confirmed. Visual inspection showed a crack along the side of the female luer as well as grooves, akin to hemostat markings, on the luer. Functional testing was performed; fluid leaked from the crack. The root cause of the crack was not identified.
 
Event Description
The customer reported a leak from a hole/crack in female luer of the "nvn filter" (neonatal venous nutrition) extension set when infusing tpn programmed at 13 ml/ hr, attached to the patient's picc line. It was reported that the set was flushed and confirmed fluid leaking out "sideways" from the female luer. The set was in use for 2 days when the leak occurred. Other infusions at the time of the event were lipids 0. 7ml/hr, vancomycin at an unspecified rate and normal saline (used for ngr, ng replacement) and gentamycin however not infusing. There was no report of patient harm.
 
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Brand NameALARIS EXTENSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7974794
MDR Text Key124009343
Report Number9616066-2018-01897
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K790108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup,Followup
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10011865
Device Catalogue Number10011865
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/17/2018 Patient Sequence Number: 1
Treatment
(3)8100,8015,(2)SECTUBING,(2)PRITUBING, TD (B)(6) 2018; THERAPY DATE (B)(6) 2018; (3)8100,8015,(2)SECTUBING,(2)PRITUBING, TD (B)(6) 2018
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