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

Model Number 2441-0007

Device Problems Separation Failure (2547); Defective Device (2588)

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

Event Date 11/25/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one 2441-0007 sample was received without packaging, however the customer indicated that the complaint sample was from lot 21075117.Residual fluid was present in the line.The sample was subjected to pressure testing, which confirmed the customer's experience; leakage was observed from a hole in the silicone tubing at the upper pumping segment tubing connector.The details of this feedback were forwarded to the manufacturing site for investigation.They confirmed that the observed damage is consistent with the component being subjected to an external force; however a review of the manufacturing and packaging process did not identify any potential sources which could cause or contribute to damage of this nature.A review of the production records for lot 21075117 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer feedback database indicates that this is a rare occurrence with this customer being the only customer to provide this type of feedback against the 2441-0007 product in the past 12 months.

Event Description

It was reported that 1 bd alaris¿ pump module smartsite¿ infusion burette set had a tear in the line, and another set's line broke off completely.The following information was provided by the initial reporter: "we have received another 2 faulty lines.1 of them has a small tear and the other line has completely broke off, this is from a different batch (10) 21075117." " was this product issue during use on a patient or before in the set up phase? the fault occurred at setup.Was a patient injured? was a staff member injured? no patient was injured.What fluids/drugs were being administered? uncertain on fluid used.Did these two sets come from the same clinical area or from two separate clinical areas? eg er as previous two sets you had provided information on yes both sets came from er.We have also asked biomed to check through the pumps on ec to make sure there is no issue with the pumps there.".

• Brand Name: BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION BURETTE 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: 13053872
• MDR Text Key: 286454722
• Report Number: 9616066-2021-52628
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403235045
• UDI-Public: 50885403235045
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2441-0007
• Device Catalogue Number: 2441-0007
• Device Lot Number: 21075117
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2021
• 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