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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION

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CAREFUSION ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INFUSION Back to Search Results
Model Number C24103E
Device Problem Stretched (1601)
Patient Problem No Information (3190)
Event Date 08/26/2019
Event Type  malfunction  
Manufacturer Narrative
An unspecified tubing concern was reported. The as-received set sample was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components. None of these were observed it was identified during inspection that there was a bulge along the silicone segment. Further handling of the observed bulge area noted it felt softer/weaker as compared to the rest of the silicone segment. No other issues were observed with the set sample. Since the observation of the bulge in the silicone segment has already been observed in a high number of previously investigated complaints, functional testing was not conducted for this failure. Previous investigation have found that a bulge can occur when an iv push medication or flush is executed below the pump without first clamping the tubing above the injection port. This action was found to result in excessive pressure within the silicone segment thus causing the silicone segment to bulge. The root cause for the source of the excessive pressure is unknown.
 
Event Description
It was reported that there was an unspecified tubing concern. It was not known if the event occurred during infusion or priming of the iv set. The customer provided a photo of the iv tubing. Although requested, there is no further patient or event information available.
 
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Brand NameALARIS PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INFUSION
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
sylvia ventura
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key9480918
MDR Text Key190982542
Report Number9616066-2019-03673
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 08/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberC24103E
Device Catalogue NumberC24103E
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/25/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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