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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2021
Type of Reportable Event	Malfunction
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 also notified the fda via medwatch # (b)(4).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 3 bd alaris pump module smartsite burette infusion sets experienced component separation.The following information was provided by the initial reporter: the blue stopper/rubber top of a gammagard s/d 50ml bottle fell into the medication bottle as bottle was being spiked with a buretrol tubing setup.Bottle was due to be spiked; primed, and then medication to be administered to patient.It has been noted that with previous setups; that spiking could create a vacuum causing the buretrol to compress inwards.Therefore, prior to spiking this bottle; rn inserted a blunt needle with a syringe (no additional air injected into bottle).Syringe removed to decompress and let air out of bottle.Blunt needle removed.When spiking the bottle, the blue stopper/rubber top fell into glass bottle.Process was stopped and bottle put aside.Pharmacists mentioned this is third time this has happened recently.
Additional Manufacturer Narrative
H.6.Investigation: due to no photo or sample being received for investigation, the customer's complaint of separation cannot be verified and the root cause remains unknown.A device history record review for model 2447-0007 lot number 21076214 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of separation with lot #21076214 regarding item #2447-0007 a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of separation regarding item #2447-0007 over the 12 month period before this complaint.
Event or Problem Description
It was reported that 3 bd alaris pump module smartsite burette infusion sets experienced component separation.The following information was provided by the initial reporter: the blue stopper/rubber top of a gammagard s/d 50ml bottle fell into the medication bottle as bottle was being spiked with a buretrol tubing setup.Bottle was due to be spiked; primed, and then medication to be administered to patient.It has been noted that with previous setups; that spiking could create a vacuum causing the buretrol to compress inwards.Therefore, prior to spiking this bottle; rn inserted a blunt needle with a syringe (no additional air injected into bottle).Syringe removed to decompress and let air out of bottle.Blunt needle removed.When spiking the bottle, the blue stopper/rubber top fell into glass bottle.Process was stopped and bottle put aside.Pharmacists mentioned this is third time this has happened recently.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12888305
• Report Number: 9616066-2021-52500
• Device Sequence Number: 16524162
• 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): 12/01/2021

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: 07/22/2024
• Device Model Number: 2447-0007
• Device Catalogue Number: 2447-0007
• Device Lot Number: 21076214
• 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: 11/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 11/29/2021
• Supplement Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• 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: 12 YR
• Patient Sex: Male