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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 2420-0500
Device Problems Improper Flow or Infusion (2954); Infusion or Flow Problem (2964)
Patient Problem No Code Available (3191)
Event Date 10/25/2018
Event Type  Injury  
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 an occlusion alarm occurred on a pump and could not be cleared.The user observed that the set had collapsed inside of the pumping module.A blood pressure medication was being administered at the time of the event, and some small blood pressure variability was noted during troubleshooting.The user massaged the tubing and continued the infusion.No other effect to the patient was reported.Biomed conducted an investigation on the set and found that the set was visibly deformed and fused.
 
Event Description
The customer reported that an occlusion alarm occurred on a pump and could not be cleared.The user observed that the set had collapsed inside of the pumping module.A blood pressure medication was being administered at the time of the event, and some small blood pressure variability was noted during troubleshooting.The user massaged the tubing and continued the infusion.No other effect to the patient was reported.Biomed conducted an investigation on the set and found that the set was visibly deformed and fused.
 
Manufacturer Narrative
The customer¿s report of an occlusion alarm and collapsed tubing was not confirmed.Visual inspection showed no anomalies.There was no evidence of the pump chamber being collapsed.Functional testing found no anomalies.The root cause of the customer¿s report could not be identified.
 
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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 Key8117186
MDR Text Key128854664
Report Number9616066-2018-02353
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012591
UDI-Public7613203012591
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Type of Report Initial,Followup
Report Date 11/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2420-0500
Device Catalogue Number2420-0500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/29/2018
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8015,8100, TD (B)(6) 2018.
Patient Outcome(s) Other;
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