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

Model Number 2420-0007

Device Problems Stretched (1601); Material Deformation (2976)

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

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

The product has been received and investigation has not been completed.A supplemental mdr will be submitted with the results of the failure investigation when it is complete.

Event Description

It was reported that during an iv infusion of normal saline, the device started beeping and when the nurse opened the door, a bubble was noted in the silicone segment of the tubing.This event occurred in medical intensive care unit (micu).There was no patient harm.

Manufacturer Narrative

The customer¿s report that a bubble in the tubing's silicone segment had formed was confirmed by visual inspection.However, the probable cause identified from previous investigations have found that bubble/ balloon can occur when an iv push medication or flush is executed below the pump without first clamping the tubing injection port.This action was found to result in excessive pressure within the silicone segment thus causing the silicone segment to bubble/ balloon.The customer¿s report that the iv infusion pump started beeping was not confirmed.The device, pump drip chamber and pcu that were in use at the time of the customer event were not returned investigation.The set was visually inspected for kinks, incomplete bonding engagements, holes/ tears in the tubing or damages to the components.During inspection it was observed that the silicone segment tubing had a bubble starting at the ring retainer of the upper fitment.Clear liquid was observed inside both the set¿s tubing and the drip chamber.No other anomalies were observed on the set during visual inspection.The customer¿s report that a bubble in the tubing's silicone segment had formed was confirmed.The root cause is unknown.

Event Description

It was reported that during an iv infusion of normal saline, the device started beeping and when the rn opened the door, a "bubble" was noted in the silicone segment of the tubing.This event occurred in medical intensive care unit (micu).A photo of the tubing was provided by the customer.It was confirmed there was no patient harm as a result of this event.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9140427
• MDR Text Key: 160740121
• Report Number: 9616066-2019-02691
• 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: 09/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• 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: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100, 8015, THERAPY DATE (B)(6) 2019; 8100, 8015, THERAPY DATE (B)(6) 2019