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

Catalog Number 2426-0500

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Hypoglycemia (1912)

Event Date 08/21/2023

Event Type  Injury  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.E1: initial reporter address: (b)(6).E4.The initial reporter also notified the fda on 23 aug, 2023.Medwatch report # mw5145028.H3.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd alaris pump module smartsite infusion set flow issues.The following was received by the initial reporter with the verbatim: patient had insulin drip infusing with bd alaris pump infusion set ref 2426-0500 the titration orders showed to stop infusion as patient bs(blood sugar) 86 nurse stopped infusion removed tubing from pump.Nurse did not close roller bar when removing from pump.Safety mechanism on tubing was engaged when removed from pump.Patient had a hypoglycemic event.Discovered that safety mechanism was not keeping insulin from dripping when tubing was removed from pump.Patient poc glucose 35 at 12:38 at 12:57 after treatment poc glucose 146.

Event Description

No additional information was provided mat# 2426-0500.Batch# unknown.It was reported by the customer that patient had insulin drip infusing with bd alaris pump infusion set ref (b)(4).The titration orders showed to stop infusion as patient bs (blood sugar) 86 nurse stopped infusion removed tubing from pump.Nurse did not close roller bar when removing from pump.Safety mechanism on tubing was engaged when removed from pump.Patient had a hypoglycemic event.Discovered that safety mechanism was not keeping insulin from dripping when tubing was removed from pump.Patient poc glucose 35 at 12:38 at 12:57 after treatment poc glucose 146.Verbatim: complaint received via email.Email(s) attached.Patient had insulin drip infusing with bd alaris pump infusion set ref (b)(4) the titration orders showed to stop infusion as patient bs(blood sugar) 86 nurse stopped infusion removed tubing from pump.Nurse did not close roller bar when removing from pump.Safety mechanism on tubing was engaged when removed from pump.Patient had a hypoglycemic event.Discovered that safety mechanism was not keeping insulin from dripping when tubing was removed from pump.Patient poc glucose 35 at 12:38 at 12:57 after treatment poc glucose 146.Add info received 2nd customer response: are you able to provide the batch number? no.What is the patient outcome? are there any adverse events/serious injuries? no treated hypoglycemic event patient returned to baseline.Was there a delay of, or change in, the course of treatment due to the event? no what type of procedure is being performed? iv infusion of insulin.What was the alaris pump module model in use at the time of the event (8100, 8110, 8120)? n/a tubing not the pump.What was the intended programming (rate, volume, duration, etc.)? 0 infusion had been stopped and removed form pump.What was the actual rate and duration time of the infusion? n/a.Was the fluid hung as a primary or secondary (piggyback) infusion? n.A.

Manufacturer Narrative

No product or photo was returned by the customer.The customer complaint of insulin continuing to drip even while the safety clamp was closed could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.

• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17839442
• MDR Text Key: 324530821
• Report Number: 9616066-2023-01972
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: (01)37613203021006
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2426-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• 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