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

Catalog Number UNKNOWN

Device Problems Infusion or Flow Problem (2964); Air/Gas in Device (4062)

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

Event Date 01/19/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that unspecified bd infusion set was expanded with air bubble the following information was received by the initial reporter with the following verbatim: rcc received a complaint via email.Email(s) attached.An issue has been reported to mms through mail.Kindly review the reported issue rn programmed infusion on lvp and had an air-in-line alarm.Rn assessed the tubing and opened lvp door to find a large bubble in the pumping segment.Rn did not save primary infusion set, but obtained new set and used the same lvp.Educator on (b)(6) provided picture to cec while on site for sms visit.¿ i am attaching the source mail, kindly review and confirm if any pr needs to be created from mds end.Disposable issue.

Manufacturer Narrative

It was reported by customer that rn programmed infusion on lvp and had an air-in-line alarm.Rn assessed the tubing and opened lvp door to find a large bubble in the pumping segment.One photo was received of an infusion set.Evaluation of the photo shows that the silicone tubing of the pumping segment is ballooning at the connection of the silicone tubing to the upper pumping segment fitting.The customer complaint of bulge/balloon of silicone segment was confirmed.Due to no physical sample being received, an investigation could not be performed and a root cause could not be determined.A device history record review could not be performed because the material number and lot number is unknown.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 was provided.Material#: unknown, batch number#: unknown.It was reported by customer that rn programmed infusion on lvp and had an air-in-line alarm.Rn assessed the tubing and opened lvp door to find a large bubble in the pumping segment.Rn did not save primary infusion set, but obtained new set and used the same lvp.Educator on (b)(6) provided picture to cec while on site for sms visit.Verbatim#: rcc received a complaint via email.Email(s) attached.An issue has been reported to mms through mail.Kindly review the reported issue rn programmed infusion on lvp and had an air-in-line alarm.Rn assessed the tubing and opened lvp door to find a large bubble in the pumping segment.Rn did not save primary infusion set, but obtained new set and used the same lvp.Educator on (b)(6) provided picture to cec while on site for sms visit.¿ i am attaching the source mail, kindly review and confirm if any pr needs to be created from mds end.Disposable issue.

• Brand Name: UNSPECIFIED BD 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: 18674928
• MDR Text Key: 334983975
• Report Number: 9616066-2024-00210
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1