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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION PRIMARY TUBING SETS; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION PRIMARY TUBING SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number PRI TUBING
Device Problem Material Rupture (1546)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 02/27/2020
Event Type  malfunction  
Manufacturer Narrative
No product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.
 
Event Description
It was reported from 3w (med-surg) that the silicone segment burst open while the iv pantoprazole 80mg in 100 ml ns bag was infusing.The iv drip appeared to have fully infused, but there was leak on the floor and inside the pump.There was no adverse effects or serious injury caused to the patient.
 
Event Description
It was reported from 3w (med-surg) that the silicone segment burst open while the iv pantoprazole 80mg in 100 ml ns bag was infusing.The iv drip appeared to have fully infused, but there was leak on the floor and inside the pump.There was no adverse effects or serious injury caused to the patient.
 
Manufacturer Narrative
Supplemental mdr created to include h7/h9 recall (z-1768-2019) for the concomitant pump.
 
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Brand Name
PRIMARY TUBING SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key9954298
MDR Text Key193615793
Report Number9616066-2020-01319
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Remedial Action Recall
Type of Report Initial,Followup
Report Date 03/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/13/2020
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/11/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1768-2019
Patient Sequence Number1
Treatment
8100,8015, THERAPY DATE 02/27/2020
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