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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 2426-0007
Device Problems Device Displays Incorrect Message (2591); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer. The customer¿s complaint of the balloon in the silicone segment was confirmed per picture received from the customer. It was observed per picture received that the silicone segment tubing had a ballooned bulge near the upper portion of the upper fitment. The root cause for this event could not be determined.
 
Event Description
The customer reported a bulge in the pumping segment of the set installed in channel a. This module had been infusing ns at kvo but was then turned off to run an infusion on channel b; the line was not clamped. Vidaza was administered on channel b at an unspecified rate via a short primary set that was connected to the primary set in channel a at the port just below the pump. When the vidaza administration was complete in channel b, channel a was then turned on to infuse a normal saline flush and it immediately alarmed for a channel error. When the nurse opened the pump door of channel a, ballooning was noted in the pumping segment just below the upper fitment. It was reported that no iv push had been given prior to the channel error, no pressure bags were used, the patient¿s central line gave a positive blood return, and all clamps were checked and unclamped before pressing start. There was no patient harm.
 
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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 Key7234756
MDR Text Key98847719
Report Number9616066-2018-00111
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Other Device ID Number10885403227998
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2018
Was Device Evaluated by Manufacturer? No
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: 02/01/2018 Patient Sequence Number: 1
Treatment
(2)8100, 8015, PRI TUBING, CENTRAL LINE, TD UNK
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