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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 2426-0500
Device Problem Stretched (1601)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2018
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
The customer reported the set had a bulge in the pump segment when used with the pump module. The customer tried "reworking" the set, but the bulge did not dissipate. There was no report of patient harm.
 
Manufacturer Narrative
The affected product has been received and the investigation is pending. A follow up report will be submitted once the failure investigation has been completed.
 
Event Description
The customer reported that in pediatric hematology/oncology, the set had a bulge in the pump segment when used with the pump module. The customer tried "reworking" the set, but the bulge did not dissipate. There was no report of patient harm.
 
Manufacturer Narrative
Initial visual inspection observed no obvious bulging. Attached to its topmost smartsite port (located above the silicone segment) was a used bd 10ml syringe (approximately 5ml remaining). The pump segment in the area directly below the upper fitment component was observed to be more pliable when compared to the rest of the silicone segment. Priming of the set was not able to replicate a bulge. Functional testing confirmed a bulge directly below the upper fitment component when performing a test infusion. Using the remaining fluid within the attached syringe, the fluid was pushed through; the silicone segment area directly below the upper fitment component and the tubing had a bulge. The bulge was manually cleared and the test infusion resumed. When the returned syringe was attached to the smartsite port located below the silicone segment, applying the roller clamp above this port, and pushing the fluid through, there was no bulging. The root cause was not identified.
 
Event Description
The customer reported that in pediatric hematology/oncology, the set had a bulge in the pump segment when used with the pump module. The customer tried "reworking" the set, but the bulge did not dissipate. There was no report of patient harm.
 
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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
MDR Report Key7810178
MDR Text Key118029869
Report Number9616066-2018-01457
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup,Followup
Report Date 08/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0500
Device Catalogue Number2426-0500
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/29/2018
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 08/23/2018 Patient Sequence Number: 1
Treatment
8015,8100, THERAPY DATE UNK; BD 10ML SYRINGE 0.9% NACL, TD (B)(6) 2018; 8015,8100, THERAPY DATE UNK
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