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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 10013890
Device Problems Material Puncture/Hole (1504); Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2020
Event Type  malfunction  
Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
 
Event Description
It was reported that during an infusion the tubing appeared to have micro holes where the fluid appeared to seep from the tubing where the cartridge is inserted into the pump.It was reported no medical treatment was required as a result of the event.
 
Manufacturer Narrative
The customer's report that during an infusion the tubing appeared to have micro holes where the fluid appeared to seep from the tubing where the cartridge is inserted into the pump was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.A small hole was observed in the silicone tubing just below the upper fitment retainer ring.No gouge/crush marks were observed on the upper fitment.Clear liquid was observed in the set¿s drip chamber and entire length of tubing.No other abnormalities were observed with the set.Functional testing was performed.Blue-dyed water was observed to be dripping out of the location of the hole in the silicone segment tubing.The seeping of fluid was due to a hole in the silicone tubing just below the upper fitment retainer ring.The root cause of the hole could not be definitively determined.
 
Event Description
It was reported that during an infusion the tubing appeared to have micro holes where the fluid appeared to seep from the tubing where the cartridge is inserted into the pump.It was reported no medical treatment was required as a result of the event.
 
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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 Key10026616
MDR Text Key189925093
Report Number9616066-2020-01560
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403232268
UDI-Public10885403232268
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 04/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10013890
Device Catalogue Number10013890
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
8100,8015,NON-BD LUER LOCK CONNECTOR,TD (B)(6) 2020; 8100,8015,NON-BD LUER LOCK CONNECTOR,TD (B)(6) 2020
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