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

Catalog Number 2420-0004

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

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 bd alaris¿ pump module administration set was damaged, causing leakage.The following information was provided by the initial reporter: "giving set has a tiny hole and leaks".

Event Description

It was reported bd alaris¿ pump module administration set was damaged, causing leakage.The following information was provided by the initial reporter: "giving set has a tiny hole and leaks.".

Manufacturer Narrative

Investigation summary: one 2420-0004 sample was received without packaging for investigation; the customer indicated that the complaint sample was from lot 20125563.The sample was received connected to a fresenius kabi 100ml rigid container of paracetamol; residual fluid was present in the product.No further information was available to assist the investigation in this instance.Functional testing confirmed the customer's experience as leakage was observed from a small hole in the tubing approximately twenty centimeters above the back check valve.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the assembly process did not identify a definitive source which may have contributed to damage of this nature and a definitive root cause could not be determined.A review of the production records for lot 20125563 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.Although definitive root cause for the tubing damage could not be determined in this instance, as a result of similar feedback, the manufacturing site have identified a number of improvement actions within the manufacturing process which should ensure the likelihood of reports of this nature are reduced in future.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the 2420-0004 product over the past 12 months.

• Brand Name: BD ALARIS¿ PUMP MODULE ADMINISTRATION 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12817977
• MDR Text Key: 283267640
• Report Number: 9616066-2021-52426
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 11/23/2021

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 Expiration Date: 12/18/2023
• Device Catalogue Number: 2420-0004
• Device Lot Number: 20125563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 11/23/2021
• Supplement Dates FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• 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