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

Model Number 2426-0007

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

The product has been received.A follow up report will be submitted with failure investigation results upon completion of the investigation.

Event Description

It was reported that the nurse opened the device door in response to an air in line alarm and found that the tubing set had separated from the upper fitment.Customer reported there was no medical intervention and no patient adverse effects caused from this event; however, the patient did not receive approximately 30 ml of their treatment of intravenous immunoglobulin related to the event.

Event Description

It was reported that the nurse opened the device door in response to an air in line alarm and found that the tubing set had separated from the upper fitment.Customer reported there was no medical intervention and no patient adverse effects caused from this event; however, the patient did not receive approximately 30ml of their treatment of intravenous immunoglobulin related to the event.

Manufacturer Narrative

Please disregard this record as it was submitted as a duplicate.The customer's report was already captured under manufacturer report number 9616066-2020-01977.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMIN, INTRAVASCULAR.
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10137528
• MDR Text Key: 194617082
• Report Number: 9616066-2020-01901
• 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
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2023
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 20036429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100, 8015, THERAPY DATE (B)(6) 2020; 8100, 8015, THERAPY DATE (B)(6) 2020