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

Catalog Number	10839681
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3.The date received by manufacturer has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris extension set leaked at the lumen of a port that was not in use resulting in hypotension and need for fluid resuscitation.The following information was provided by the initial reporter: our adult micu experienced issues with bd smallbore extension set.The feedback below came from nursing staff: patient received on same dose of levo and vaso running through triflo lumen.Doses were not changed, but midshift, patient's bp was 70s/40s, primary rn going up on levo and vaso, but patient bp was not responding.Primary rn noticed that patient's gown was wet and noticed that the medication was leaking through one of the lumens on the triflo that was not connected to a medication.Of note, that lumen was not clamped.Primary rn clamped lumen, resuscitated with ns bolus (as per order) and was able to come down on the pressor doses to baseline.
Event or Problem Description
It was reported that bd alaris extension set leaked at the lumen of a port that was not in use resulting in hypotension and need for fluid resuscitation.The following information was provided by the initial reporter: our adult micu experienced issues with bd smallbore extension set.The feedback below came from nursing staff: patient received on same dose of levo and vaso running through triflo lumen.Doses were not changed, but midshift, patient's bp was 70s/40s, primary rn going up on levo and vaso, but patient bp was not responding.Primary rn noticed that patient's gown was wet and noticed that the medication was leaking through one of the lumens on the triflo that was not connected to a medication.Of note, that lumen was not clamped.Primary rn clamped lumen, resuscitated with ns bolus (as per order) and was able to come down on the pressor doses to baseline.
Additional Manufacturer Narrative
H.6.Investigation summary: no product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the lot number is unknown.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.

• Brand Name: BD ALARIS EXTENSION SET
• Common Device Name: 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17702699
• Report Number: 9616066-2023-01860
• Device Sequence Number: 7511017
• Product Code: FPA
• UDI-Device Identifier: 50885403234536
• UDI-Public: (01)50885403234536
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 10839681
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown