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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 10015489
Device Problem Stretched (1601)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/08/2017
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 1000ml baxter iv infusion bag. The customer¿s report that the silicone had ballooned was confirmed. A visual inspection of the returned sample noted that the silicone tubing was slightly expanded ("ballooned") close to the upper pumping component. The sample was subjected to functional testing; the customer's report could only be confirmed if the roller clamp was closed and fluid was injected through the smartsite just below the pumping segment as this caused fluid to go back up the line and pressure started to build up due to the back check valve which caused the silicone tubing to expand. The root cause of ballooning in the silicone is caused by administering an iv push without clamping the line above the injection port creating an internal high pressure.
 
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 information received suggests that the pump was on hold as the user believed the iv access was blocked. The set was kinked above the port and the line was flushed to clear the occlusion at which point the pump alarmed channel error. When the user opened the door to investigate, they found that the silicone had ballooned up. 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
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key6891147
MDR Text Key118484175
Report Number9616066-2017-01290
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/25/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10015489
Device Catalogue Number10015489
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/26/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/25/2017 Patient Sequence Number: 1
Treatment
8015,8100, THERAPY DATE 01/01/2017
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