MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number 2420-0007

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/02/2023

Event Type  Injury  

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set over-infused heparin during the infusion.As a result, protamine sulfate was ordered for a 62.5mg iv push with a rate of 5mg/min, and a head ct scan was performed, which came back negative.The following information was provided by the initial reporter: "received a copy of medwatch report from fda which states, "pump malfunction; heparin overdose; nurse report: rn noticed at around 0300, that entire 250ml heparin bag infused over the course of about four hours.I hung a new bag at 2314, paused it at 0024 due to a high anti xa, then resumed at 0100.This appears to be a pump issue due to there still being a volume to be infused of 204.2ml, despite the empty bag of heparin.I stopped the infusion, pa notified and came to bedside.Protamine sulfate ordered, 62.5mg iv push with a rate of 5mg/min.Patient will be going for a head ct.It turned out negative, clinical engineering tested the pump and supplied tubing, able to duplicate a short burst of free flow of around 15-20 ml every 5 minutes or so.When i use my test tubing the free flow does not happen.".

Manufacturer Narrative

Medical device expiration date: unknown.Fda notified?: the initial reporter also notified the fda via medwatch # mw5116503.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

Correction h5: imdrf annex e grid: e2403, h5: imdrf annex f grid: f12.

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set over-infused heparin during the infusion.As a result, protamine sulfate was ordered for a 62.5mg iv push with a rate of 5mg/min, and a head ct scan was performed, which came back negative.The following information was provided by the initial reporter: "received a copy of medwatch report from fda which states, "pump malfunction; heparin overdose; nurse report: rn noticed at around 0300, that entire 250ml heparin bag infused over the course of about four hours.I hung a new bag at 2314, paused it at 0024 due to a high anti xa, then resumed at 0100.This appears to be a pump issue due to there still being a volume to be infused of 204.2ml, despite the empty bag of heparin.I stopped the infusion, pa notified and came to bedside.Protamine sulfate ordered, 62.5mg iv push with a rate of 5mg/min.Patient will be going for a head ct.It turned out negative, clinical engineering tested the pump and supplied tubing, able to duplicate a short burst of free flow of around 15-20 ml every 5 minutes or so.When i use my test tubing the free flow does not happen.".

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set over-infused heparin during the infusion.As a result, protamine sulfate was ordered for a 62.5mg iv push with a rate of 5mg/min, and a head ct scan was performed, which came back negative.The following information was provided by the initial reporter: "received a copy of medwatch report from fda which states, "pump malfunction; heparin overdose; nurse report: rn noticed at around 0300, that entire 250ml heparin bag infused over the course of about four hours.I hung a new bag at 2314, paused it at 0024 due to a high anti xa, then resumed at 0100.This appears to be a pump issue due to there still being a volume to be infused of 204.2ml, despite the empty bag of heparin.I stopped the infusion, pa notified and came to bedside.Protamine sulfate ordered, 62.5mg iv push with a rate of 5mg/min.Patient will be going for a head ct.It turned out negative, clinical engineering tested the pump and supplied tubing, able to duplicate a short burst of free flow of around 15-20 ml every 5 minutes or so.When i use my test tubing the free flow does not happen.".

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.It was reported by the customer that there was a heparin overdose, rn noticed that entire 250ml heparin bag infused over the course of about four hours.The customer complaint could not be verified due to the product not being returned for failure investigation.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review could not be performed on model 2420-0007 because a lot number is unknown.

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16922819
• MDR Text Key: 315170938
• Report Number: 9616066-2023-00880
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 07613203021012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2023

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: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/21/2023
• Initial Date FDA Received: 05/12/2023
• Supplement Dates Manufacturer Received: 06/28/2023; 07/19/2023
• Supplement Dates FDA Received: 07/13/2023; 08/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention