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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 2477-0007
Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/27/2020
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.Per customer, it is their policy not to provide patient demographics.
 
Event Description
It was reported that the blood tubing set was primed and no leak was observed.After loading the set into the pump, blood was seen dripping from the bottom of the pump.Infusion was immediately stopped and upon inspection, blood was also seen inside the pump module.A tiny tear on the pump segment was noted.There was no patient harm.A photo of the product was provided by the customer.The clinician believes that the pump might have caused the tubing to tear.
 
Manufacturer Narrative
Additional information added; d.10, h.7, and h.9.The customer report that the tubing leaked at the pumping segment was confirmed.Inspection of the set's silicone segment component observed there was a tear, directly below the upper fitment component.A leak was observed from the tear during testing.The set was pressure tested with intent of applying air pressure throughout the set the fluid within the set leaked from the tear at 5psi.The root cause of the tear was not identified.
 
Event Description
It was reported that the blood tubing set was primed and no leak was observed.After loading the set into the pump, blood was seen dripping from the bottom of the pump.Infusion was immediately stopped and upon inspection, blood was also seen inside the pump module.A tiny tear on the pump segment was noted.There was no patient harm.A photo of the product was provided by the customer.The clinician believes that the pump might have caused the tubing to tear.
 
Manufacturer Narrative
The customer report that the tubing leaked at the pumping segment was confirmed.Visual inspection showed a tear in the silicone segment directly below the upper fitment component.The tear was measured approximately 0.0127 inches in length.Fluid was observed leaking from the tear.The set was pressure tested and the fluid within the set leaked from the tear at 5psi.The root cause of the tear was not identified.Functional testing with the returned pump could not be performed due to the tear in the silicone tubing segment.The returned concomitant pump module was routed to service for preventative maintenance/testing before being returned to the customer.The bezel was found to be affected by the alaris pump 8100 separated bezel boss recall and was replaced.However, this issue was unrelated to the tubing tear.The pump passed testing and no fault was found.Device history record for model 2477-0007 lot 19106339 shows that the set was manufactured on 24 october 2019 with a total of 17,283 units.There were no qn¿s (quality notification) issued during the production build of this lot for the failure mode reported.
 
Event Description
It was reported that the blood tubing set was primed and no leak was observed.After loading the set into the pump, blood was seen dripping from the bottom of the pump.Infusion was immediately stopped and upon inspection, blood was also seen inside the pump module.A tiny tear on the pump segment was noted.There was no patient harm.A photo of the product was provided by the customer.The clinician believes that the pump might have caused the tubing to tear.
 
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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 Key9788325
MDR Text Key191285114
Report Number9616066-2020-00672
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203019460
UDI-Public7613203019460
Combination Product (y/n)N
PMA/PMN Number
K894842
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 02/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/24/2022
Device Model Number2477-0007
Device Catalogue Number2477-0007
Device Lot Number19106339
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1768-2019
Patient Sequence Number1
Treatment
8100,8015, TD 01/27/2020
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