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

Model Number 2420-0500

Device Problems Stretched (1601); Deformation Due to Compressive Stress (2889)

Patient Problem No Information (3190)

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.

Event Description

It was reported that tubing set inside the lvp pump was ballooning instead of infusing.

Event Description

It was reported that tubing set inside the lvp pump was ballooning instead of infusing.Although requested, there has been no impact to patient response or additional event information made available to date.

Manufacturer Narrative

Additional information added; h.6.(device code).The customer¿s report of ballooning 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 a balloon in the silicone tubing pump segment near the upper fitment.No other anomalies or evidence of damage were observed.Examination under magnification of the silicone tubing segment walls were found to be concentric.Functional testing resulted in no ballooning.The root cause for the source of the excessive pressure is unknown.

• 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: 9716640
• MDR Text Key: 191694848
• Report Number: 9616066-2020-00480
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 7613203012430
• 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: 01/29/2020

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: 12/06/2022
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: 19125579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/17/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CUROS CAP, THERAPY DATE UNK