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

Catalog Number	2441-0007
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd alaris pump module smartsite infusion burette set was occluded the following information was received by the initial reporter with the following verbatim it was reported by customer that the clinicians would spike the iv bag but ¿no fluid¿ would go into the buretrol chamber.Attempted to squeeze the buretrol chamber and they still could not get any medication to come out of the iv bag.They were ultimately able to get it work by hanging the iv set upside down and ¿backwards¿ flushing the iv set.
Event or Problem Description
Material # 2441-0007, batch # unknown.It was reported by customer that the clinicians would spike the iv bag but ¿no fluid¿ would go into the buretrol chamber.Attempted to squeeze the buretrol chamber and they still could not get any medication to come out of the iv bag.They were ultimately able to get it work by hanging the iv set upside down and ¿backwards¿ flushing the iv set.Verbatim: rcc received a complaint via email.Email(s) attached.Buretrols ¿bad batch¿ ref#(b)(4) mds complaint - please notify mds team.The clinicians would spike the iv bag but ¿no fluid¿ would go into the buretrol chamber.Attempted to squeeze the buretrol chamber and they still could not get any medication to come out of the iv bag.They were ultimately able to get it work by hanging the iv set upside down and ¿backwards¿ flushing the iv set.The clinicians reported the issue and lot number to supply chain, it occurred about a month ago and it has not happened again since.Customer response received on (b)(6) 2024.1.Can you please provide an exact date of event for the incident in this format dd-mmm-yyyy? first formal report: (b)(6) 2024.Second formal report: (b)(6) 2024.2.Please share the material & lot number for the disposable product bd alaris pump infusion burette set; ref (b)(4).There is not a lot number printed on the paper insert.For both products, packaging was discarded prior to event.3.Describe any patient harm, injury, complication or negative outcome that occurred as a result of this events.One patient was receiving amphotericin b daily at 1500.Due to the time sensitivity of this drug and the need for it to be administered quickly after compounding, the buretrol issues caused the nursing staff to plan for a significant amount of time to prep the medication prior to administration.The continued issues with the buretrols caused a significant stress to the bedside nursing staff as this patient was on this medication for weeks.4.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? the product was not saved for both of these formal reports.However, we are still seeing these issues intermittently with the buretrols.Customer response received on (b)(6) 2025.1.As stated, 'first formal report: (b)(6) 2024 and second formal report: (b)(6) 2024.' could you please confirm whether the incident occurred on both of these dates? yes those are the icare dates for the documented occurrences of this malfunction.
Additional Manufacturer Narrative
No product or photo was returned by the customer.The customer complaint of flow issues fluid blockage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 2441-0007 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.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE INFUSION BURETTE 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21120761
• Report Number: 9616066-2024-02224
• Device Sequence Number: 12621542
• Product Code: FPA
• UDI-Device Identifier: 10885403235047
• UDI-Public: (01)10885403235047
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K022209
• Number of Events Summarized: 1
• Summary Report (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): 01/23/2025

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
• Operator of Device: Other
• Device Catalogue Number: 2441-0007
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown