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

Model Number 2426-0007

Device Problems Material Separation (1562); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the tubing is missing blue rings which causes the tubing to separate during use.There was no harm to patient.

Manufacturer Narrative

Correction: d.4.Additional information added; d.10, d.11, & h.6.The customer¿s report that the tubing was missing the blue ring which caused the tubing to separate was confirmed.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Visual inspection observed that the silicone segment was separated from the lower fitment at the pump segment.The ring retainer was not received with the set and a ring retainer indentation was not observed around the end of the silicone pump tubing where the separation occurs.Closer inspection under a lab microscope observed no indication of damage or tool marks on the pump segment.Functional testing could not be performed due to the separation and obvious leaking that would occur.The silicone pump tubing and fitment were found to be within measurement specification(s).The root cause of the primary set silicone segment separation was due to the set's retainer ring not assembled onto the set during manufacturing assembly process.

Event Description

It was reported from the pediatric bone marrow unit that the tubing was missing blue ring which causes the tubing to separate during use.There was no harm to patient.

Manufacturer Narrative

Additional information provided in b.3.

Event Description

It was reported from the pediatric bone marrow unit, that the tubing was missing a blue ring, which caused the tubing to separate during use.It was further confirmed during follow up, that there was no patient harm or impact as a result of 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: 9434335
• MDR Text Key: 188691890
• Report Number: 9616066-2019-03594
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• 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,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• 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: 12/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ONE CUROS CAP.