MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET,ADMINISTRATION,INTRAVASCULAR

Model Number 2420-0007

Device Problems Break (1069); Fluid/Blood Leak (1250); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

Race and ethnicity: white.The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.

Event Description

It was reported when the rn arrived at the patient's bedside found that the iv that was connected to the patient was broken in two.It was found to be broken about 4 inches below the pump with the other half still connected to the patient.The patient at this time was experiencing confusion, acutely disoriented, anxious, and intervening with other forms of treatment such as picking at dressings covering wounds and pulling out the second iv that was not in use.The rn heard the iv pole being jostled prior to entering the room.The patient grabbed the iv tubing and pulled on it hard enough to break it and the medication (heparin) leaked on the floor.Although it was reported that patient care was delayed it did not contribute to, or result in serious adverse impact to patient.

Manufacturer Narrative

The customer¿s report that the tubing broke at junction ¿separated¿ was confirmed during visual inspection.The set was visually inspected for cracks, misassembles or damages to the components.Visual inspection confirmed that the tubing was completely separated from the tubing adapter.Closer inspection of the separation under a lab microscope observed that the adapter had insufficient solvent applied at the engagement during the manufacturing process.The tubing adapter was measured and found to be within specification(s).Functional testing was not necessary as it is obvious that a leak would occur as a result of the separation.The root cause of the separation was a manufacturing issue for insufficient solvent being applied at the engagement of the tubing due to equipment and/ or operator error.

Event Description

It was reported when the rn arrived at the patient's bedside it was observed that the iv that was connected to the patient was broken in two.It was found to be broken about (4) inches below the pump with the other half still connected to the patient.The patient at this time was experiencing confusion, acutely disoriented, anxious, and intervening with other forms of treatment such as picking at dressings covering wounds and pulling out the second iv that was not in use.The rn heard the iv pole being jostled prior to entering the room.The patient grabbed the iv tubing and pulled on it hard enough to break it and the medication (heparin) leaked on the floor.Although it was reported that patient care was delayed, it was confirmed during follow up that this event did not contribute to, or result in any serious adverse impact, nor require any medical intervention for the patient.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET,ADMINISTRATION,INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9282843
• MDR Text Key: 165981949
• Report Number: 9616066-2019-03132
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 61 YR