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

Catalog Number 10942011

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 04/09/2023

Event Type  malfunction  

Event Description

It was reported that the bd alaris pump module infusion set was found with a small hole and leaked.The following information was provided by the initial reporter: new iv bag tubing was primed with normal saline then taken into the patient room.Antibiotics were scanned, hung, and started.Registered nurse noticed that the tubing was dripping.Small hole was found in the tubing.New tubing was primed and the antibiotics were restarted.

Manufacturer Narrative

E4.The initial reporter also notified the fda via medwatch # (b)(4).A.2.Date of birth: patient¿s birthday was not provided, (b)(6) 2011 was used based on age of patient.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary a complaint of tubing having a small hole causing leakage was received from the customer.No product or photo was returned by the customer.The customer complaint of component damage - leak could not be verified due to the product not being returned for failure investigation.A device history record review for model 10942011 lot number 23025288 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 no sample being received, an investigation could not be performed, and a root cause could not be determined.

Event Description

It was reported that the bd alaris pump module infusion set was found with a small hole and leaked.The following information was provided by the initial reporter: new iv bag tubing was primed with normal saline then taken into the patient room.Antibiotics were scanned, hung, and started.Registered nurse noticed that the tubing was dripping.Small hole was found in the tubing.New tubing was primed and the antibiotics were restarted.

• Brand Name: BD ALARIS PUMP MODULE 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16946419
• MDR Text Key: 315859952
• Report Number: 9616066-2023-00921
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403232404
• UDI-Public: (01)10885403232404
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931173
• 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: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10942011
• Device Lot Number: 23025288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2023
• 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
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 88 KG