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

Catalog Number 10013361

Device Problems Leak/Splash (1354); Deformation Due to Compressive Stress (2889)

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

Event Date 12/12/2022

Event Type  malfunction  

Event Description

It was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing was kinked and leaked during use.The event of kinked tubing happened 14 times in lot 21125226, and 4 times in lot 21086491.The following information was provided by the initial reporter: "we are seeing ¿defective¿ infusion pump sets.The tubing coming out of the drip chamber is crimped (bent) and impeding the flow out of the drip chamber.We are also seeing leaks in the tubing at this crimp area as well.It looks like this is creating a weak spot in the tubing and forcing the solution past the crimped tubing is causing leaks.We are using this tubing for chemo and optima sets.Was there any patient impact/harm? if so was there a need for any medical treatment or intervention? no patient harm, one report of leaking occurring at the site of the bent/crimped tubing set that did not make it to the patient.".

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 21125226, medical device expiration date: 03-dec-2024, and device manufacture date: 02-dec-2021.Medical device lot #: 21086491, medical device expiration date: 30-aug-2024, and device manufacture date: 27-aug-2021.Device evaluated by mfr: 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 the bd alaris¿ pump module smartsite¿ infusion set tubing was kinked and leaked during use.The event of kinked tubing happened 14 times in lot 21125226, and 4 times in lot 21086491.The following information was provided by the initial reporter: "we are seeing ¿defective¿ infusion pump sets.The tubing coming out of the drip chamber is crimped (bent) and impeding the flow out of the drip chamber.We are also seeing leaks in the tubing at this crimp area as well.It looks like this is creating a weak spot in the tubing and forcing the solution past the crimped tubing is causing leaks.We are using this tubing for chemo and optima sets.Was there any patient impact/harm? if so was there a need for any medical treatment or intervention? no patient harm, one report of leaking occurring at the site of the bent/crimped tubing set that did not make it to the patient.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 17-jan-2023.H6: investigation summary seventeen samples of material 10013361 were received for quality investigation.The customer complaint of bent/deformed damaged was verified by inspection.Fourteen samples of lot number 21225226 and three samples of lot number 21086491 were submitted.Kinking of the tubing under the drip chamber was evident in all the samples submitted.Priming of all the samples was then attempted, in order to conduct a simulated infusion.One sample of lot number 21225226 did not allow for fluid flow, approximately 2 inches, past the kink below the drip chamber.The remaining samples of lot 21225226 did not have any issues with occlusion or flow.Two samples of lot number 21086491showed signs of a slow flow through the infusion set.The remaining sets had kinks but did not have any flow issues or occlusion.A device history record review for model 10013361 lot number 21125226 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 10013361 lot number 21086491 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the issue seen in this complaint is the excessive time that the infusion set is in an assembly fixture causing the kinks below the drip chamber.The reason why the infusion set was in the assembly fixture too long was due to human error.A quality alert was issued, and additional training was conducted with production personnel in order to correct the issue.

• 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: 16212516
• MDR Text Key: 308650747
• Report Number: 9616066-2023-00034
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403221965
• UDI-Public: 10885403221965
• 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: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 10013361
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• 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