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

Model Number 2426-0007

Device Problem Excess Flow or Over-Infusion (1311)

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

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd alaris pump module smartsite infusion set over-infusion occurred.There was no report of patient impact.The following information was provided by the initial reporter: #1 it was reported by the customer that the bag emptied was far greater then it was programed for.Verbatim: this is the 2nd occurance i have been made aware of.  the secondary iv tubing is backing up into the primary bag and not being delivered to the patient.  all iv tubing is set up correctly, with primary hung from the extension hook, so that fluid is pulled from the highest bag first (secondary).   the first time it was only discovered because the rate that the secondary emptied was far greater then it was programed for.

Event Description

It was reported while using bd alaris pump module smartsite infusion set over-infusion occurred.There was no report of patient impact.The following information was provided by the initial reporter: #1 it was reported by the customer that the bag emptied was far greater then it was programed for.Verbatim: this is the 2nd occurence i have been made aware of.The secondary iv tubing is backing up into the primary bag and not being delivered to the patient.All iv tubing is set up correctly, with primary hung from the extension hook, so that fluid is pulled from the highest bag first (secondary).The first time it was only discovered because the rate that the secondary emptied was far greater then it was programed for.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 16-sep-2022.H6: investigation summary : one sample model ms3500-15 was returned for investigation.The set was examined for defects and abnormalities.No defects or abnormalities were observed.No additional testing was conducted as no primary set was returned.The root cause could not be determined because the primary set was not returned.A device history record review could not be performed because a lot number was not provided by the customer.

• 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 ; 8015296192
• MDR Report Key: 15415256
• MDR Text Key: 306174318
• Report Number: 9616066-2022-01327
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403227996
• UDI-Public: 50885403227996
• 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
• Report Date: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: MS3500-15 - BD 36 IN 15 DROP SECONDARY SET W/HGR