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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 Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/26/2020
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
It was reported that while troubleshooting a repeated occlusion alarm during an infusion of insulin that had ben infusing for 5 hours in the operating room, it was noticed that the tubing set developed a bulge in the pump segment tubing.The tubing was reinserted into the pump and the pump appeared to function.The case finished without issue.The tubing was collected after the issue and appeared to be normal at the end of the case.It was reported there was no adverse events.
 
Event Description
It was reported that while troubleshooting a repeated occlusion alarm during an infusion of insulin that had ben infusing for 5 hours in the operating room, it was noticed that the tubing set developed a bulge in the pump segment tubing.The tubing was reinserted into the pump and the pump appeared to function.The case finished without issue.The tubing was collected after the issue and appeared to be normal at the end of the case.It was reported there was no adverse events.
 
Manufacturer Narrative
Additional info: d.11;g.5.The customer¿s report of a balloon in the tubing set was confirmed during pressure testing.Visual inspection did not observe any anomalies.Testing concluded no occlusion alarms or ballooning/bulge were observed on the pumping segment during an infusion device testing.However, during pressure testing a balloon bulge was observed on the silicone segment below the upper fitment.Further visual inspection under magnification found the walls of the silicone tubing segment to be concentric.The root cause could not be definitively determined.
 
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Brand Name
ALARIS PUMP MODULE ADMINISTRATION SET
Type of Device
SET,ADMINISTRATION,INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key10126309
MDR Text Key194307291
Report Number9616066-2020-01892
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 company representative,health
Type of Report Initial,Followup
Report Date 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2426-0007
Device Catalogue Number2426-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8100,8015, TD (B)(6) 2020.; RED CAP, TD (B)(6) 2020.
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