MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD AS LVP 20D LOW SORB; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 2260-0006

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that bd as lvp 20d low sorb over infused.The following information was provided by the initial reporter with the verbatim: - we just received a patient back from cardiac surgery and during the surgery the anesthetist reported to me that the alaris pump model 8100 sn (b)(6) delivered a bolus of medication dexmedetomidine whilst programmed to run at 8 ml /hr and the bag was almost empty (the patient received 76ml 0f the medication) when it was programmed at 8ml/hr.I have a video of the fluid pouring out of the line while it was disconnected from the patient after they realized what happened.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd as lvp 20d low sorb over infused.The following information was provided by the initial reporter with the verbatim: we just received a patient back from cardiac surgery and during the surgery the anesthetist reported to me that the alaris pump model 8100 sn (b)(6) delivered a bolus of medication dexmedetomidine whilst programmed to run at 8 ml /hr and the bag was almost empty (the patient received 76ml 0f the medication) when it was programmed at 8ml/hr.I have a video of the fluid pouring out of the line while it was disconnected from the patient after they realized what happened.

Manufacturer Narrative

H.6.Investigation summary: no samples were received for investigation of pr 8666571, in which the customer has observed flow rate accuracy issues with the pumping segment.The product in use at the time is reported to be 2260-0006 from lot 21076391.No further information was available to assist the investigation in this instance.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21076391 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined in this instance as no sample was received for investigation.Without a sample to examine it is not possible to determine whether a manufacturing defect could have caused or contributed to a report of this nature.In this instance, without the complaint sample to examine it has not been possible to conclusively link this feedback to a specific failure mode; however, a review of the customer feedback database indicates that this is a rare occurrence with a small number of similar reports against the product 2260-0006 in the past 12 months.

• Brand Name: BD AS LVP 20D LOW SORB
• 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: 17691298
• MDR Text Key: 322744294
• Report Number: 9616066-2023-01828
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012103
• UDI-Public: (01)37613203012103
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2260-0006
• Device Lot Number: 21076391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• 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