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

Catalog Number 7N8399

Device Problems Leak/Splash (1354); Material Opacification (1426); Split (2537); Material Deformation (2976)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 04/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient started bleeding during an open heart surgery due to a leak in a one-link needlefree iv (intravenous) connector, which occurred after the connector was exposed to a collodian remover (non-baxter product).It was reported that a one-link needlefree iv connector split, became cloudy, misshapen and began leaking after being exposed to a collodian remover.The incident involved an infant who had undergone open heart surgery and had extracorporeal membrane oxygenation.The electroencephalograph leads had been removed from the patient and the patient had started to bleed shortly after removal.The location of the blood loss was the right internal jugular.The tubing was removed and the issue was discovered.It was reported that the collodian remover appeared to have "some type of chemical reaction to the set when it was unintentionally applied." the portion of the set affected was replaced immediately and the bleeding was stopped.There was a "significant amount" of blood loss, however, it was difficult to quantify (no further detail was provided).The doctor stated that the patient had done well in the surgery.No further detail on the patient's outcome was provided.No additional information is available.

Manufacturer Narrative

(b)(4).A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional test, clear passage and pressure test were performed with satisfactory results.The reported condition was not verified.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: 5005383
• MDR Text Key: 23088119
• Report Number: 1416980-2015-32549
• 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,other
• Reporter Occupation: Physician
• Report Date: 09/03/2015

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 Expiration Date: 05/02/2020
• Device Catalogue Number: 7N8399
• Device Lot Number: UR15E02016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/14/2015
• 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): Required Intervention