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

Model Number 2426-0500

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 02/02/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the infusion pumps were transferred to iv poles and patient was transported computed tomography (ct) scan department.While patient was in ct scan, the blood pressure significantly dropped to 68 mmhg despite titrating the levophed infusion from 0.2mcg/kg/min to 0.95mcg/kg/min.Patient's blood pressure was stable all day prior to the event.Upon inspection, a small hole "pinhole" was found in the tubing just below the pump segment and the levophed solution was leaking onto the floor.The clinicians further noted that the drop in blood pressure was also attributed to derecruitment of patient's lung regions (i.E., airway and alveolar closure) when the patient was taken off the ambu bag (bag valve mask device) and switched to mechanical ventilator, because the patient also had a drop in oxygen saturation (spo2) that required interventions.The rn called the physician over the phone and immediately provided verbal order for epinephrine iv, which was given to the patient after being obtained from the code cart.The patient's blood pressure recovered, and the physician immediately came down to the ct scan room to intervene as well.The patient was brought back to trauma and neurosurgery intensive care unit (tnicu) for further management.Patient's systolic blood pressure and oxygen saturation recovered.The charge rn, resource nurse and icu fellow were informed.

Manufacturer Narrative

The customer¿s report that the hole ¿cut/slice in tubing and leaked" was confirmed.Visual inspection observed a cut/slice on the tubing just below the second smartsite outlet port below the lower fitment.During functional testing the set leaked from the tubing cut that was observed during visual inspection.The root cause of the hole ¿cut¿ was not identified.

Event Description

It was reported that the infusion pumps were transferred to iv poles and patient was transported computed tomography (ct) scan department.While patient was in ct scan, the blood pressure significantly dropped to 68 mmhg despite titrating the levophed in 0.9% normal saline 500ml infusion from 0.2mcg/kg/min to 0.95mcg/kg/min.Patient's blood pressure was stable all day prior to the event.Upon inspection, a small hole "pinhole" was found in the tubing just below the pump segment and the levophed solution was leaking onto the floor.The leak was not noticed until the nurse investigated why the patient was not responding to the infusion.The clinicians further noted that the drop in blood pressure was also attributed to derecruitment of patient's lung regions (i.E., airway and alveolar closure) when the patient was taken off the ambu bag (bag valve mask device) and switched to mechanical ventilator, because the patient also had a drop in oxygen saturation (spo2) that required interventions.The rn called the physician over the phone and immediately provided verbal order for epinephrine iv, which was given to the patient after being obtained from the code cart.The patient's blood pressure recovered, and the physician immediately came down to the ct scan room to intervene as well.The patient was brought back to trauma and neurosurgery intensive care unit (tnicu) for further management.Patient's systolic blood pressure and oxygen saturation recovered.The charge rn, resource nurse and icu fellow were informed.

• 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: 9714843
• MDR Text Key: 181441839
• Report Number: 9616066-2020-00437
• Device Sequence Number: 1
• Product Code: FPA
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/07/2020

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 Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/14/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, TD (B)(6) 2020; BAXTER INFUSION BAG, TD (B)(6) 2020
• Patient Outcome(s): Required Intervention
• Patient Age: 34 YR