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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - HAINA EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - HAINA EXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 7N8332K
Device Problem Disconnection (1171)
Patient Problem Death (1802)
Event Type  Death  
Manufacturer Narrative
The patient's age was reported as 15 or 16 years old. The event occurred on an unknown date in (b)(6) 2019. The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. There is no indication that the disconnection itself was caused by defective product. The customer reported that the one-link components disconnected from the female luer of the one-link catheter extension sets during infusion. The one-link components in 7n8332k are not bonded to the female luer of the extension sets. The one-link component is intentionally not bonded, by design, to allow the clinicians to remove the one-link component if needed. Because the set is not bonded, the labeling for 7n8332k (0719000041) has the following statements to ensure users check the connections prior to use: ¿secure in-line luer connections¿ and ¿ensure all in-line luer connections are secure prior to use. ¿ the luer connections in the one-link component have been verified to iso luer standards to ensure the quality of the luer connections. The customer reported they have newly converted over to using the baxter bifuse and trifuse products and were previously using carefusion¿s bifuse/trifuse products that had bonded injection sites. Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported a pediatric patient was admitted to the pediatric intensive care unit for treatment following an unspecified drug overdose. During treatment, the nurse observed that the one-link extension set became disconnected from the ¿trifuse¿ one-link device during an infusion of epinephrine. Subsequently, the patient ¿coded¿ (cardiopulmonary arrest). It was reported the epinephrine line was reconnected and the patient recovered ¿to survive for organ donation¿. It was reported that the patient passed away, (date unknown) due to the drug over dose; however, it was additionally reported "the official cause of death was unknown". It was not reported if an autopsy was performed. No additional information is available.
 
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Brand NameEXTENSION SETS WITH ONE-LINK NEEDLE-FREE LV CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - HAINA
haina, san cristobal
Manufacturer (Section G)
BAXTER HEALTHCARE - HAINA
piisa industrial park antigua
carretera sanchez km 18 1/2
haina, san cristobal 91000
DR 91000
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8718873
MDR Text Key148732771
Report Number1416980-2019-03373
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132734
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number7N8332K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/20/2019 Patient Sequence Number: 1
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