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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH EPUMP 1000ML PUMP SET; PUMP, INFUSION, ENTERAL
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CARDINAL HEALTH EPUMP 1000ML PUMP SET; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 773656
Medical Device Problem Code Air/Gas in Device (4062)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/20/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
 
Event or Problem Description
Customer reports: moc noticed that there was air in the tubing of a kangaroo pump 2x, and notified the rn.When the rn entered the room there was still plenty of formula in the actual bag, however there was air noted to be in the tubing.Moc verbalized that this happened yesterday as well and the pump and bag were changed out yesterday.The rn called biomed and labeled pump as defective.New kangaroo pump and tubing were hung.No issues thus far with new set up.
 
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Brand Name
EPUMP 1000ML PUMP SET
Common Device Name
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
CARDINAL HEALTH
15 hampshire street
mansfield MA 02048
MDR Report Key12436422
Report Number1282497-2021-10593
Device Sequence Number5723649
Product Code LZH
UDI-Device Identifier10884521022096
UDI-Public10884521022096
Combination Product (Y/N)N
Initial Reporter StateCO
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 09/07/2021
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
Operator of Device No Information
Device Model Number773656
Device Catalogue Number773656
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/31/2021
Initial Report FDA Received Date09/07/2021
Patient Sequence Number1
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