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

Model Number 2420-0007

Device Problems Backflow (1064); Fluid/Blood Leak (1250)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 10/19/2019

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.Patient age and dob requested but not provided, however, the customer stated that the patient was an adolescent patient.

Event Description

It was reported that the patient experienced blood backing up into iv tubing while receiving dextrose 5% and 0.25% normal saline with 20meq of potassium chloride infusing at 20 ml/hr.Upon review by the bedside rn, a leak was noted at the y-port closest to patient side.The tubing was changed three times between (b)(6) 19th and 20th, with the same results.It was believed that the leak caused the backup of blood.The blood would clear with flushing but then it begins backing up again.The patient's peripherally inserted central catheter (picc) clotted and required administration of cathflo to dissolve the blood clot.However, picc was ultimately removed due to concern for infection.There was no delay in patient therapy and there was no known deep vein thrombosis (dvt) or infection that has been identified on the patient to date.

Manufacturer Narrative

The customer¿s report that there was a leak from the y-port (smartsite) and that blood backed up was confirmed.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection observed a small puncture hole on the top of the piston of the set¿s distal smartsite valve at the center.No tool marks or other anomalies were observed.Functional testing replicated a leak at the distal y-port (smartsite) during priming.A leak was observed from the center of the distal smartsite¿s blue piston where the damage was noted.No other leaks or anomalies were observed.The root cause is due to a manufacturing issue of a combination of factors explained in conclusion.

Event Description

It was reported that the patient experienced blood backing up into iv tubing while receiving dextrose 5% and 0.25% normal saline with 20meq of potassium chloride infusing at 20 ml/hr.Upon review by the bedside rn, a leak was noted at the y-port closest to patient side.The tubing was changed three times between october 19th and 20th, with the same results.It was believed that the leak caused the back-up of blood.The blood would clear with flushing but then it begins backing up again.The patient's peripherally inserted central catheter (picc) clotted and required administration of cathflo to dissolve the blood clot.However, the picc was ultimately removed due to concern for infection.There was no delay in patient therapy and there was no known deep vein thrombosis (dvt) or infection, that has been identified on the patient to date.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9312500
• MDR Text Key: 184689348
• Report Number: 9616066-2019-03251
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• 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: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, PICC, THERAPY DATE: (B)(6) 2019.