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

Catalog Number 2C6401

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/10/2014

Event Type  malfunction  

Event Description

It was reported that an interlink solution set leaked from ¿right above the luer¿ during priming with 0.9% sodium chloride solution.The reporter stated that the leak was ¿pretty significant,¿ and led to the solution leaking onto her skin.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Upon completion of the investigation, or if any additional relevant information is received, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Investigation summary: baxter received one sample for evaluation.Visual and microscopic inspections were performed.The tubing connected to the drip chamber was found to be crimped inside the connection to the drip chamber.A functional flow test was performed by attaching the set to an in-house solution bag; the solution flowed with no problems.A leak was observed where the tubing was crimped.A leak test was performed and a leak was verified at the connection of the tubing to the drip chamber.The cause was determined to be ineffectiveness and inconsistency of sensor detection and also re-applying the solvent after machine stoppages that might lead insufficient solvent on tubing.To correct the issue the sensor position was optimized and inspected for proper function at all solvent application stations.In addition awareness training was provided for the operators.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 - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3910830
• MDR Text Key: 19804348
• Report Number: 1416980-2014-21360
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C6401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2014
• 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
• Treatment: 0.9% SODIUM CHLORIDE SOLUTION