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

Model Number 2420-0007

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

Patient Problem No Information (3190)

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.Patient's demographics requested, but was not provided.

Event Description

It was reported that during an infusion, the iv tubing set ballooned/bubbled.

Manufacturer Narrative

Additional information provided: d.4, d.10, g.5, & h.6.(device code).************************************************************************** the customer¿s report that the iv tubing set ballooned/bubbled was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection of the set noted clear liquid within the tubing from the drip chamber to the pump segment.At the top of the silicone pump segment tubing near the upper fitment, a small balloon was observed.There were no other anomalies observed.Functional testing resulted in no ballooning.Further visual inspection of the inner diameter of the silicone tubing observed to be concentric.The root cause for the source of the excessive pressure was not determined.

Event Description

It was reported that during an infusion, the iv tubing set "ballooned/bubbled".Although requested, there has been no further patient or event information made available to date.

• 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: 9359257
• MDR Text Key: 190508372
• Report Number: 9616066-2019-03435
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• 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: 11/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1