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

Catalog Number 11426965

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 during use with an unspecified amount of bd alaris¿ pump module smartsite¿ infusion set the tubing is knotting and has caused delays in surgery so the knots can be removed.This has been occurring several times for an extended amount of time.The following information was provided by the initial reporter: the customer reported, they had encountered knotting with the primary iv tubing.Customer asking has there been a change to the tubing or the packaging? the staff say the tubing seems longer.Furthermore, one of the nurses say that if you don¿t pull it out of the packaging in such a manner that it will easily knot.Additional information obtained from customer: did the event interrupt treatment, or cause a clinically significant delay in treatment, that negatively impacted the patient? if yes, please provide details.Yes, surgery has been delayed due to the need to remove knots in tubing when patient arrives in (or) operation room.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 30-jun-2023.H6: investigation summary a complaint of set being easy to tangle, longer in length and kinking was received from the customer.An unopened sample was received for investigation.Through visual inspection, no defects or damages were observed inside the packaging.The package was opened, and the set was inspected for kinks or damages.Kinks and damage were not noted on the set.The sample was measured and found to be 136", which is within specification.The set was primed and infused at a rate of 250 ml/hr.No issues were observed during infusion.A device history record review for model 11426965 lot number 23015032 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to the defect not being able to be replicated, a root cause could not be determined.

Event Description

It was reported that during use with an unspecified amount of bd alaris¿ pump module smartsite¿ infusion set the tubing is knotting and has caused delays in surgery so the knots can be removed.This has been occurring several times for an extended amount of time.The following information was provided by the initial reporter: the customer reported, they had encountered knotting with the primary iv tubing.Customer asking has there been a change to the tubing or the packaging? the staff say the tubing seems longer.Furthermore, one of the nurses say that if you don¿t pull it out of the packaging in such a manner that it will easily knot.Additional information obtained from customer: did the event interrupt treatment, or cause a clinically significant delay in treatment, that negatively impacted the patient? if yes, please provide details.Yes, surgery has been delayed due to the need to remove knots in tubing when patient arrives in or.

• 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: 17234685
• MDR Text Key: 318205257
• Report Number: 9616066-2023-01328
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232558
• UDI-Public: 10885403232558
• 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: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 11426965
• Device Lot Number: 23015032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2022
• 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