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

Model Number	10933805
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9088493
• Report Number: 9616066-2019-02680
• Device Sequence Number: 2592661
• Product Code: FPA
• UDI-Device Identifier: 07613203019088
• UDI-Public: 7613203019088
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 70001B-07T, NON-BD EXT SET,TD (B)(6) 2019