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

Model Number 2426-0007

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Patient's demographics requested, but was not provided.

Event Description

It was reported that the iv tubing had a large bubble in the silicone segment.It was discovered approximately 10 seconds after the rn spiked the saline bag to attached it to the patient and start the pump.There was no patient impact.

Manufacturer Narrative

The customer¿s report that the iv tubing had a large bubble in the silicone segment was confirmed by visual inspection.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection observed a deformation at the top of the silicone pump segment indicating that it had previously ballooned.A portion of the silicone pump segment was cut out and visually inspected under a lab microscope.The silicone pump segment was found to be within measurement specification(s) and the tubing was visually confirmed to be concentric.Previously investigated complaints determined that the ballooning is caused by excess pressure within the silicone tubing segment.The root cause of the excessive pressure is unknown.

Event Description

It was reported that the iv tubing that a large "bubble" was noticed in the silicone segment, after a "channel error" alarm occurred.It was discovered approximately (10) seconds after the rn spiked the saline bag to attach it to the patient, and start the pump.It was further confirmed during follow up, that there was no patient harm as a result of this event.

Manufacturer Narrative

Revision of b5.

Event Description

It was reported that a large "bubble" was noticed in the silicone segment, after a "channel error" alarm occurred.It was discovered approximately (10) seconds after the rn spiked the saline bag to attach it to the patient and start the pump.It was further confirmed during follow up, that 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: 9535989
• MDR Text Key: 179421040
• Report Number: 9616066-2019-03798
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/10/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2022
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 19106141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/17/2020; 01/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, CUROS CAP,TD (B)(6) 2019.