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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 PRI TUBING
Device Problems Fluid Leak (1250); Material Separation (1562)
Patient Problem Death (1802)
Event Date 09/10/2019
Event Type  Death  
Manufacturer Narrative
The customer¿s report of separated and leaked from the blue safety clamp was confirmed. Received from the customer was one partial primary set that was not able to be identified. The received partial set consisted of the tubing and components from the lower fitment and below. Visual inspection of the partial set found the set was received with a small portion of the silicone pump segment attached to the lower fitment. The ring retainer was still attached to the lower fitment. Inspection of the tear under a lab microscope observed the tear to be jagged. No tool marks were observed. No crush marks were observed on the lower fitment. No functional testing could be performed due to the tear in the silicone pump segment and the obvious leaking that would occur. Functional testing of the new unopened primary sets did not observe or replicate any leaks or tear damage. The source of the leak was due tear damage in the silicone pump segment near the upper fitment. The root cause of the tear damage could not be determined. Note: the customer sent a partial tubing set that was not able to be identified, however, the customer also sent one unused/unopened sample of tubing set material number 2420-0007, lot number 19023002 and one unused/unopened sample of tubing set material number 2420-0007, lot number 18073054. Section a. Demographics were requested, however not provided. The customer stated that the patient was an adult patient.
 
Event Description
It was reported that during a code blue on a unit, the tubing set was obtained from the code cart, attached to 1 liter normal saline, primed and inserted into a pressure bag. When the nurse inflated the pressure bag, the tubing set separated and leaked from the blue safety clamp. Although the customer stated that there was a delay in treatment and the adult patient expired, the customer further stated that the patient's death was not a result of the defective tubing set.
 
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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 Key9177022
MDR Text Key161917454
Report Number9616066-2019-02828
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 09/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPRI TUBING
Device Catalogue NumberPRI TUBING
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2019
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

Patient Treatment Data
Date Received: 10/10/2019 Patient Sequence Number: 1
Treatment
PRESSURE BAG, THERAPY DATE (B)(6) 2019
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