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

Model Number 10927766

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problems High Blood Pressure/ Hypertension (1908); Blood Loss (2597)

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.

Event Description

It was reported that 3:00 am the rn initiated a labetalol infusion at a rate of 30 ml/hr.And (vtbi) volume to be infused of 100 ml.Between 3:00 ¿ 3:30 am the patient called the rn to the room to report that something was wet on his arm.Upon observation, it was found that the labetalol was piggy backed into the iv port and the white cap had popped off the injection port, but the blue part remained in the tubing.The patient bled approximately 200-300 ml of blood onto the floor.This tubing malfunction caused an interruption in the medication administration and the patient bleeding from the site caused a drop in hgb by 1 point as well as the patient's blood pressure increased by 27 points.This resulted in increased monitoring of the patient.

Event Description

It was reported that at 3:00am the rn initiated a labetalol infusion at a rate of 30ml/hr., and a (vtbi) volume to be infused of 100ml.Between 3:00am and 3:30am, the patient called the rn to the room to report that something was wet on his arm.Upon observation, it was found that the labetalol was piggy backed into the iv port and the white cap had popped off the injection port, but the blue part remained in the tubing.The patient bled approximately 200ml - 300ml of blood onto the floor.This tubing malfunction caused an interruption in the medication administration and the patient bleeding from the site caused a drop in hgb by (1) point as well as the patient's blood pressure increased by (27) points.This resulted in increased monitoring of the patient.

Manufacturer Narrative

The customer¿s report that the white cap (fla) had popped off the injection port (smartsite) was confirmed.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.Visual inspection observed that the primary set¿s distal smartsite was broken in half where the white female luer adapter (fla) meets the transparent plastic body of the smartsite.Inspection underneath a lab microscope observed white stress marks at the break site of the fla and the transparent plastic body of the smartsite.No tool marks or other anomalies were observed throughout the set.Functional testing could not be conducted due to the break on the smartsite and an obvious leak would occur.Although the root cause could not be definitively determined, the probable root cause of the smartsite break is excessive force being applied to the smartsite as indicated by the observed stress marks.

Event Description

It was reported that at 3:00am the rn initiated a labetalol infusion at a rate of 30ml/hr., and a (vtbi) volume to be infused of 100ml.Between 3:00am and 3:30am, the patient called the rn to the room to report that something was wet on his arm.Upon observation, it was found that the labetalol was piggy backed into the iv port and the white cap had popped off the injection port, but the blue part remained in the tubing.The patient bled approximately 200ml - 300ml of blood onto the floor.This tubing malfunction caused an interruption in the medication administration and the patient bleeding from the site caused a drop in hgb by (1) point as well as the patient's blood pressure increased by (27) points.This resulted in increased monitoring of the patient.

• 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: 9410415
• MDR Text Key: 169063903
• Report Number: 9616066-2019-03541
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203019101
• UDI-Public: 7613203019101
• 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,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2022
• Device Model Number: 10927766
• Device Catalogue Number: 10927766
• Device Lot Number: 19096212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/06/2020; 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 114