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

Catalog Number 2477-0007

Device Problem Material Puncture/Hole (1504)

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

Event Date 09/20/2023

Event Type  malfunction  

Manufacturer Narrative

E4.The initial reporter also notified the fda on 21 sep, 2023.Medwatch report # mw5146147 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 blood infusion set was damaged.The following information was received by the initial reporter with the verbatim: pinhole in blood tubing resulting in leaking into the iv pump.

Manufacturer Narrative

Followup mdr submission for device evaluation: no product or photo was returned by the customer.The customer complaint that there was a pinhole in the tubing could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

Event Description

No additional information material#: 2477-0007 batch#: unknown it was reported by customer that pinhole in blood tubing resulting in leaking into the iv pump verbatim rcc received complaint via email.Email(s) attached.Pinhole in blood tubing resulting in leaking into the iv pump.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE BLOOD 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: 17954445
• MDR Text Key: 326071441
• Report Number: 9616066-2023-02109
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2477-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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