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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 Problems Stretched (1601); Deformation Due to Compressive Stress (2889)
Patient Problem Death (1802)
Event Date 09/10/2019
Event Type  Death  
Manufacturer Narrative
Concomitant medical products: 1000ml baxter bag, lot y294827, exp 07/2020, 0. 9% sodium chloride injection; pressure bag; yellow cap; therapy date: (b)(6) 2019. The customer¿s report that the tubing set developed a balloon in the silicone segment was confirmed. No ballooning/bulge was observed on the silicone segment; however, a portion of the silicone tubing segment beneath the ring retainer of the upper fitment was deformed and more elastic than the rest of the silicone tubing (6295 inches long). Functional testing was performed by using the customer provided iv bag set to prime the set. No issues were observed. Additional testing using a lab 10ml syringe filled with water was used to perform an iv push first using the set¿s distal smartsite. An iv push was performed first by occluding the tubing above the injection port per if2204 iv push tip sheet, and then again by not occluding the tubing. The iv push performed by not occluding the tubing above the injection port observed a balloon on the set. The root cause of the ballooning in the silicone segment was not definitively determined. The probable cause have found that a bubble/ balloon can occur when an iv push medication or flush is executed below the pump without first clamping the tubing injection port. This action was found to result in excessive pressure within the silicone segment, causing it to bubble/ balloon.
 
Event Description
It was reported that during a code blue on a unit, the tubing set was obtained from the code cart, attached to normal saline 1l, primed and inserted into a pressure bag. The tubing was not clamped. When the nurse inflated the pressure bag, the tubing set developed a balloon in the silicone segment. Of the tubing. 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, 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 Key9176391
MDR Text Key161918053
Report Number9616066-2019-02813
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 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 Number2420-0007
Device Catalogue Number2420-0007
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
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