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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 2420-0007
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2017
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
Received a copy of the customer's medwatch report from fda, which states "the tubing ran dry, so we attempted to back-prime tubing. During back priming process (line unclamped), the tubing formed a bubble in the portion where line is placed into iv pump. The rn then removed the tubing since it was not working properly. As tubing was removed, it broke in half. ".
 
Manufacturer Narrative
Conclusion field left blank - no available code for undetermined or unknown cause. The customer¿s report that the tubing formed a bubble in the portion where line is placed into the iv pump and as the tubing was removed, it broke in half was confirmed. The set was received separated at the engagement between the silicone tubing segment and the upper fitment. The retainer ring component for the upper fitment and silicone tubing segment connection was not returned by the customer. Indentations were observed on the silicone tubing indicating a retainer ring was installed on the tubing during manufacturing. The silicone segment tubing had slight discoloration and was weakened just below where it attaches to the upper fitment. Functional testing was not performed due to the separation of the silicone segment and upper fitment. The root cause of the balloon and tubing separation could not be determined.
 
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Brand NameALARIS® PUMP MODULE ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
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
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key6349880
MDR Text Key68035294
Report Number9616066-2017-00323
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,user faci
Reporter Occupation Risk Manager
Type of Report Initial,Followup
Report Date 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/06/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2017
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

Patient Treatment Data
Date Received: 02/22/2017 Patient Sequence Number: 1
Treatment
(B)(4), THERAPY DATE (B)(6) 2017
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