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

Catalog Number 2426-0007

Device Problem Material Rupture (1546)

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

Event Date 11/08/2023

Event Type  malfunction  

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 alaris pump module smartsite infusion set tubing ruptured.The following information was received by the initial reporter with the verbatim: productcomplaint: issue: tubing ruptured blood backflow, and leakage occurred.Medication: ns 250 was being administered.

Event Description

No new information received.Material#: 2426-0007, batch number#: 23095669.It was reported by customer that tubing ruptured blood backflow, and leakage occurred.Product complaint: facility: (b)(6), mat ref: 24260007, lot: 23095669, issue: tubing ruptured blood backflow, and leakage occurred.Doe 08nov2023, pt: no injury.Sample: the actual tubing was discarded but samples of the reported lot are available, photos available as well.Medication: ns 250 was being administered.Verbatim#: rcc received a complaint via phone.Pir attached.Product complaint: facility: (b)(6).Mat ref: 24260007, lot: 23095669, issue: tubing ruptured blood backflow, and leakage occurred.Doe 08nov2023, pt: no injury, sample: the actual tubing was discarded but samples of the reported lot are available, photos available as well.Medication: ns 250 was being administered.Customer response: tubing rupture occurred about 13 inches from the tubing spike.The slit on the tubing was protruded and was approximately 1-2 cm long.Rn was running 500 ml of ns.Please see the attached pictures.The backflow was most likely caused by this issue and occured after the rn performed pre infusion inspection.This issue occurred in a single product.

Manufacturer Narrative

The customer reported the tubing ruptured and returned photo evidence of material 2426-0007 lot 23095669.The set was visually examined for defects and abnormalities.The complaint of tubing damage, which caused backflow, was verified by the photo.The tubing cut was reported to be 13 inches from the drip chamber spike.The root cause for the cut in the tubing was not able to be found, as the physical sample investigation was unable to be performed.Device history record review for model 2426-0007 lot number 23095669 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 28sep2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18244030
• MDR Text Key: 329450035
• Report Number: 9616066-2023-02308
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: (01)10885403227998
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2426-0007
• Device Lot Number: 23095669
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 12/01/2023
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1