MAUDE Adverse Event Report: CAREFUSION 303, INC. SMARTSITE; INFUSION SET

Catalog Number 2420-0500

Device Problems Air Leak (1008); Burst Container or Vessel (1074); Device Displays Incorrect Message (2591); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 01/25/2014

Event Type  malfunction  

Event Description

The patient was receiving continuous pantoprazole (intravenous (iv) drug).The iv pump alarmed and the nurse (rn) opened the pump door to examine tubing and a large bubble was noted in chamber tubing.The rn clamped the tubing toward patient and disconnected tubing from the patient.When attempting to remove tubing from pump, the tubing in chamber burst spraying the iv drug into the rn's eyes.The rn flushed her eyes and went to emergency department (ed) for treatment.There was no harm done to patient at that time.The tubing and channel were saved for inspection.Manufacturer response: we have the investigation completed, if you have any questions let me know.Model number: 2420-0500 lot number: 13115536 event date: not provided event description: tubing burst when trying to remove from the pump.Conclusion: the report of the pump segment separating from the upper fitment was confirmed.During visual inspection of the set received it was noted that the silicone segment was separated from the upper fitment and the ring retainer was still on the silicone tubing.The upper fitment ring retainer remained in the manufacturer's location on the silicone tubing.The silicone segment was manually re-connected to the upper fitment and testing performed.The set was primed via gravity using water; no leaks were detected during the priming process.The set was loaded into a test pump and set to run at 125ml/hr.For one hour.The infusion test completed successfully without leaks, errors or alarms occurring.Functional testing was performed on the upper fitment, silicone tubing and ring retainer.All measurements were within manufacturer¿s specifications.A leak test was performed, increasing the pressure in the set by 5 psi increments, the set should not leak at the limit of 30 psi.Around 13psi a balloon developed in the silicone segment below the upper fitment and the test had to be terminated.There were no leaks found at this lower value.The root cause could not be identified.Although it was reported that no iv pushes or flushes were given, during the running of the leak test a balloon developed around 13psi.Based on previous incidents with the same type of problem description it is most likely due to an iv push being administered when the tubing above the iv push site is not clamped off.Thank you for your feedback.I totally agree you did provide a lot of useful information for us to use in our investigation.We have to base our investigation on the product we receive so if you still have the others we would be happy to take a look.We did receive your facilities copy of the submitted medwatch report from the fda; we also reported this event as it does meet our criteria.The silicone segment is press fit with the ring retainer we mentioned so if the pressure in the line exceeds 30 psi the set can come apart.Through our testing we found that smaller size syringes cause higher pressure in the line than larger syringes, so if there was an 3cc iv push as the nurse indicated on the form she filled out that could very well have been a causative factor.

• Brand Name: SMARTSITE
• Type of Device: INFUSION SET
• Manufacturer (Section D): CAREFUSION 303, INC.; 3750 torrey view court; san diego CA 92130
• MDR Report Key: 3628543
• MDR Text Key: 4203395
• Report Number: 3628543
• Device Sequence Number: 2
• Product Code: FPA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/30/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 2420-0500
• Device Lot Number: 13066239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALARIS PC PUMPING MODULE.; CHEMOTHERAPY