MAUDE Adverse Event Report: BAXTER HEALTHCARE - AIBONITO ACCESS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 7N8301

Device Problems Reflux within Device (1522); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Unspecified Infection (1930); Phlebitis (2004)

Event Type  Death  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced a blood infection coincident with the one-link catheter extension set, and the patient subsequently died.The cause of the phlebitis and resulting infection was due to backflow of blood which occurred when disconnecting from j-loop, and flushing the lines.On an unknown date, the patient was admitted to the hospital for an unrelated indication.During hospitalization the event occurred.Treatment details were not reported.On an unknown date, the patient passed away.The cause of death was reported as inconclusive and the results of the autopsy were not available.No additional information is available at this time.

Manufacturer Narrative

(b)(4).Remove check mark from product problem.It was reported that a patient experienced a blood infection coincident with the one-link catheter extension set (a neutral displacement connector).Based on follow up received from the infection preventionist, the event of backflow is no longer a causation factor associated to the event of infection.There was no detailed information reported on the infection event and clinical manifestations that could have caused the reported event of blood stream infection and subsequent death.At the time of this event (unspecified date), the reporting facility had undergone several product conversions and product changes including flush syringes and j-loops.The facility went from standard flush to positive flush syringes.(b)(4).

Manufacturer Narrative

(b)(4).The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer (Section G): BAXTER HEALTHCARE - AIBONITO; rd 721 km 0 3 po box 1389; aibonito PR 705
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5194412
• MDR Text Key: 30028406
• Report Number: 1416980-2015-40616
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 7N8301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2015
• Initial Date FDA Received: 11/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/19/2015; 12/14/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization