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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 Fluid/Blood Leak (1250); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Patient Problem Chemical Exposure (2570)
Event Type  malfunction  
Manufacturer Narrative
Although requested, device has not been received. A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
The customer reported that during the day shift when giving a bolus through the pump after a heparin infusion, the machine displayed ¿channel error¿. The patients iv tubing was kinked, massaged to seemingly continue the flow, but the pump was still showing ¿channel error¿. When opening the channel there was a bubble at the top of the tubing. When the tubing was removed, it separated from the blue connection and splashed in the nurse's eye and face. There was no lasting harm.
 
Event Description
The customer reported that during the day shift when giving a bolus through the pump after a heparin infusion, the machine displayed ¿channel error¿. The patients iv tubing was kinked, massaged to seemingly continue the flow, but the pump was still showing ¿channel error¿. When opening the channel there was a bubble at the top of the tubing. When the tubing was removed, it separated from the blue connection and splashed in the nurse's eye and face. There was no lasting harm.
 
Manufacturer Narrative
Two of the customer's reported issues were confirmed. Inspection of the set showed a separation at the engagement between the upper fitment and silicone segment components. The silicone segment was slightly pressed and it was observed that the area directly below the upper fitment was more pliable when compared to the rest of the silicone segment. Visual inspection of the separated silicone segment showed no obvious bulging, kinks, damage, or other issues. Pressure testing replicated a bulge in the silicone. The customer's report that the tubing kinked was not confirmed. The root cause was not identified. The customer's report that the tubing ballooned at the pumping segment was confirmed. The balloon was caused by excessive pressure within the silicone segment which caused the silicone segment to balloon/bulge. The root cause for the source of the excessive pressure is unknown. The customer's report that the tubing leaked was confirmed. The leak was due to the observed set separation. The root cause of the separation was not identified.
 
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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 Key8182863
MDR Text Key131332608
Report Number9616066-2018-02565
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403227998
UDI-Public10885403227998
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 11/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/20/2018
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: 12/19/2018 Patient Sequence Number: 1
Treatment
8015,8100,TD UNK
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