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

Model Number	2447-0007
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd alaris pump module smartsite burette infusion set was clogged.The following information was provided by the initial reporter: trying to prime ivig (intravenous immune globulin) and noticed that the medication wasn't going into the ball chamber in order to prime.Squeezed it multiple times, flipped it around, opened all the clamps, but it wasn't going into the ball chamber.Had to remove the ivig in the burette since it wouldn't prime.No harm came to the patient, but luckily, we were able to pull the medication out of the chamber with the port attached.
Additional Manufacturer Narrative
Date of birth: only the patient's age was provided, therefore a default date of birth has been listed.Fda notified: the initial reporter notified the fda via uf/importer report#: (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint that the product won't prime could not be verified due to the product not being returned for failure investigation.A device history record review for model 2447-0007 lot number 21095293 was performed.The search showed that a total of (b)(6) in 1 lot number was built on 09sep2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
Event or Problem Description
It was reported that the bd alaris pump module smartsite burette infusion set was clogged.The following information was provided by the initial reporter: trying to prime ivig (intravenous immune globulin) and noticed that the medication wasn't going into the ball chamber in order to prime.Squeezed it multiple times, flipped it around, opened all the clamps, but it wasn't going into the ball chamber.Had to remove the ivig in the burette since it wouldn't prime.No harm came to the patient, but luckily, we were able to pull the medication out of the chamber with the port attached.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE BURETTE INFUSION 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14347485
• Report Number: 9616066-2022-00568
• Device Sequence Number: 5009995
• Product Code: FPA
• UDI-Device Identifier: 50885403235076
• UDI-Public: 50885403235076
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2022

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 Expiration Date: 09/09/2024
• Device Model Number: 2447-0007
• Device Catalogue Number: 2447-0007
• Device Lot Number: 21095293
• 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: 04/19/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 05/10/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• 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
• Patient Age: 16 YR
• Patient Sex: Male