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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR

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CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2420-0007
Device Problem Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/20/2017
Event Type  malfunction  
Manufacturer Narrative
The customer¿s report of a bulge during use was confirmed. Visual inspection observed that the silicone segment had bulge below the upper pumping segment component. A closer inspection noted some kinks in the tubing. No flow restrictions were identified during functional testing. The root cause of the bulge is from administering an iv push without clamping the line above the injection port which can create an internal pressure high enough to cause this effect.
 
Manufacturer Narrative
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 silicone segment was reported to have bulged during clinical use. No additional information available. From the reported information there are no indications of serious injury to the patient or user as a result of this incident.
 
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Brand NameALARIS® PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7190159
MDR Text Key280744426
Report Number9616066-2018-00055
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 01/15/2018 Patient Sequence Number: 1
Treatment
50ML SODIUM CHLORIDE FLUID BAG; 8015,8100, THERAPY DATE (B)(6) 2017
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