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

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that during infusion of an unspecified medication, the iv tubing set separated at the clamp portion of the silicone segment.When observed, the medication was dripping out of the pump near the pump segment.The medication bag was immediately turned upside down to avoid losing anymore medication, then the iv tubing set and pump module were replaced.This caused a delay in the treatment, however; there was no patient impact.

Event Description

It was reported that during infusion of an unspecified medication, the iv tubing set separated at the clamp portion of the silicone segment.When observed, the medication was dripping out of the pump near the pump segment.The medication bag was immediately turned upside down to avoid losing anymore medication, then the iv tubing set and pump module was replaced.This caused a delay in the treatment, however; there was no patient impact.

Event Description

It was reported that during infusion of an unspecified medication, the iv tubing set separated at the clamp portion of the silicone segment.When observed, the medication was dripping out of the pump near the pump segment.The medication bag was immediately turned upside down to avoid losing anymore medication, then the iv tubing set and pump module were replaced.This caused a delay in the treatment, however; there was no patient impact.

Manufacturer Narrative

No product will be returned per customer.The customer's complaint of tubing separated at safety clamp was confirmed.Photo provided by the customer shows that the (pvc) tubing was separated from the lower fitment.The root cause is due to combination of factors related to insufficient solvent and improper assembly due to equipment and/or operator error.

• 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: 9533561
• MDR Text Key: 191290932
• Report Number: 9616066-2019-03768
• 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: 12/09/2019

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: 10/16/2022
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 19105907
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/03/2020; 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015, 8100, THERAPY DATE (B)(6) 2019
• Patient Age: 62 YR