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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 2426-0007
Device Problems Fluid Leak (1250); Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/13/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: 100ml hospira bag ndc 0409-7984-37, lot 88-059-jt, exp 1apr2020, 0. 9% sodium chloride injection. Requested patient demographics however not provided. The devices have been received and the evaluation is pending. A follow up report will be submitted with investigation results once the evaluation has been completed.
 
Event Description
The customer reported a leak from a pin hole in the tubing, the leak was located 6 in. From the drip chamber and the bag spike. There was no report of patient harm. Although requested there are no additional information about the patient, medication or event provided by customer.
 
Manufacturer Narrative
The customer¿s report of a leak from a pin hole in the tubing was confirmed. Visual inspection found a cut in the tubing approximately 6 inches below the drip chamber. During functional testing the set leaked from the tubing approximately 6 inches below the drip chamber. The root cause of the cut could not be identified.
 
Event Description
The customer reported a leak from a pin hole in the tubing, the leak was located 6 in. From the drip chamber and the bag spike. There was no report of patient harm. Although requested there are no additional information about the patient, medication or event provided by customer.
 
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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 Key8207323
MDR Text Key131769902
Report Number9616066-2018-02640
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
Report Date 12/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/02/2021
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot Number18055139
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2018
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: 12/31/2018 Patient Sequence Number: 1
Treatment
20028E,MS3500-15, TD (B)(6) 2018
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