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

Model Number 2426-0007

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

Event Description

It was reported that the iv pump alarmed and nursing noticed a visible bulge in the tubing just below the blue upper fitment.There was no patient harm.This event occurred in the icu.

Manufacturer Narrative

The customer¿s report that there was a visible balloon in the silicone segment just below the blue upper fitment was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing, or damage to the components.Visual inspection of the set noted a balloon in the silicone tubing pump segment near the upper fitment.No other anomalies or evidence of damage were observed.Functional testing resulted in the set re-priming successfully with no issues observed.The infusion completed with no alarms or any issues.The silicone tubing segment was cut and inspected under magnification; the walls were found to be concentric.The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported from the (icu) that the iv pump alarmed and nursing noticed a visible "bulge" or "balloon" in the silicone segment just below the blue upper fitment.It was further stated that there were no adverse effects caused to the patient from this event.

Manufacturer Narrative

Additional information provided: b.5.Patient demographics requested but not provided, however the customer stated that the patient was an adult patient.

Event Description

It was reported from the icu that the iv pump alarmed and nursing noticed a visible "bulge" or "balloon" in the silicone segment just below the blue upper fitment during the primary infusion of an unspecified medication via a peripheral line.It was noted that there was no indication of an iv push medication prior to the event.It was further stated that there were no adverse effects caused to the adult patient from this event.

• 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: 9633396
• MDR Text Key: 186725462
• Report Number: 9616066-2020-00273
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, THERAPY DATE: (B)(6) 2020.; RED CAP.