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

Model Number 2260-0500

Device Problem Failure to Deliver (2338)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd alaris pump module low sorbing set there was a blockage during infusion.There was no report of patient impact.The following information was provided by the initial reporter: rn noted infusion was not dripping.Alaris pump did not alarm and gave no indication that fluid was not being delivered.Iv tubing removed from channel and on inspection it was noted that tubing appeared to be fused together inside channel.

Manufacturer Narrative

Investigation summary no product or photo was returned by the customer.The customer complaint that the set was unable to be flushed could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model 2260-0500 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.

Event Description

It was reported while using bd alaris pump module low sorbing set there was a blockage during infusion.There was no report of patient impact.The following information was provided by the initial reporter: rn noted infusion was not dripping.Alaris pump did not alarm and gave no indication that fluid was not being delivered.Iv tubing removed from channel and on inspection it was noted that tubing appeared to be fused together inside channel.

• Brand Name: BD ALARIS PUMP MODULE LOW SORBING 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16527365
• MDR Text Key: 311244738
• Report Number: 9616066-2023-00427
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203012608
• UDI-Public: (01)37613203012608
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K931173
• 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: 03/31/2023

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: Health Professional
• Device Model Number: 2260-0500
• Device Catalogue Number: 2260-0500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/13/2023
• Supplement Dates Manufacturer Received: 03/31/2023
• Supplement Dates FDA Received: 06/06/2023
• 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