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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP 1000ML SAFETY SCREW SPIK; PUMP, INFUSION, ENTERAL
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CARDINAL HEALTH EPUMP 1000ML SAFETY SCREW SPIK; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 775100
Device Problem Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/18/2023
Event Type  malfunction  
Event Description
The customer reported over the weekend they had multiple instances of the feed tubing for the kangaroo pumps (one bag and one spike for the feed bottle) that have not primed successfully.All the instances they have had issues with involve the priming process and the tubing pulling air instead of feed or pulling air in addition to feed making the tubing foamy and insufficiently primed.Today they successfully primed the pump with a third set of tubing from the same lot number that worked as expected.
 
Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
 
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Brand Name
EPUMP 1000ML SAFETY SCREW SPIK
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
CARDINAL HEALTH
777 west street
mansfield MA 02048
Manufacturer (Section G)
CARDINAL HEALTH
calle 9 sur no. 125 cuidad ind
tijuana 22500
MX   22500
Manufacturer Contact
jill saraiva
777 west street
mansfield, MA 02048
5086183640
MDR Report Key18491958
MDR Text Key333109360
Report Number9612030-2024-00013
Device Sequence Number1
Product Code LZH
UDI-Device Identifier10884521155817
UDI-Public10884521155817
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 01/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number775100
Device Catalogue Number775100
Device Lot Number2318517864
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/19/2023
Type of Device Usage A
Patient Sequence Number1
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