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

Model Number 10933805

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported that the iv infusion pump was alarming while infusing 1 liter of normal saline at 500ml/hr prior to a chemotherapy infusion.The nurse was unable to recall the device's exact onscreen alarm message, but states it was either "occlusion" or "air-in-line".When the nurse opened the device's door, it was found that a bubble has formed on the tubing's silicone pump segment near the upper fitment.There was no patient harm.Photo of the tubing was provided by the customer.

Manufacturer Narrative

The customer¿s report that a bubble had formed on the silicone pump segment was confirmed.The report that the pump alarmed for either "occlusion" or "air in line" was not confirmed.During inspection, no bubbles were observed on the silicone pumping segment; however, the a small portion of the silicone tubing below the upper fitment was softer and more elastic than the rest of the silicone tubing.Clear liquid was observed inside both the primary and secondary tubing and drip chambers.Functional testing was performed; no issues were observed.An iv push was performed by occluding the tubing above the distal smartsite.This process was repeated for the middle smartsite.No issues were noted by the device.The silicone segment did not bubble and the device did not alarm.Pressure testing was performed.A bubble in the tubing was observed at 18 psi near the upper fitment.After the functional testing, three samples of the silicone segment were analyzed and the walls were found to be concentric.The device pump and pcu that were in use at the time of the reported event were not returned for investigation.The root cause of the silicone segment bubble was not definitively determined.

Event Description

It was reported that the iv infusion pump was alarming while infusing 1 liter of normal saline at 500ml/hr prior to a chemotherapy infusion.The nurse was unable to recall the device's exact onscreen alarm message, but states it was either "occlusion" or "air-in-line".When the nurse opened the device's door, it was found that a bubble has formed on the tubing's silicone pump segment near the upper fitment.There was no patient harm.Photo of the tubing was provided by the customer.

• 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: 9088493
• MDR Text Key: 159357667
• Report Number: 9616066-2019-02680
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019088
• UDI-Public: 7613203019088
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10933805
• Device Catalogue Number: 10933805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 70001B-07T, NON-BD EXT SET,TD (B)(6) 2019