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

Model Number	10015896
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.2.Patient¿s birthday was not provided, (b)(6) 1975 was used based on age of patient.D.4.Medical device expiration date: unknown.E.4.: the initial reporter also notified the fda.Medwatch report #mw5115936.H.4.Device manufacture date: unknown.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 while using bd alaris pump module smartsite infusion set the tubing separated.There was no report of patient impact.The following information was provided by the initial reporter: iv tubing broke at a connection where the tubing should be sealed.The tubing was not pulled or yanked, it just fell apart.Once the disconnection was noted, the entire iv tubing was removed and bagged.There was no air in the short pigtail and the iv was easily flushed and had good blood return.New tubing was connected and the iv infusion was resumed.No need to remove or restart the iv.Event did not cause any delay in treatment or prevent a timely discharge.
Additional Manufacturer Narrative
H6: investigation summary the customer reported the tubing came apart without any pulling or yanking, and returned a photo.The photo verifies the complaint, and the separation happened at the silicon upper fitment.The ring retainer can be clearly seen as still there, and this is the deciding factor in the root cause.Without the blue ring retainer, the error is deemed manufacturing.When it is attached, the error falls to use error.A device history record review could not be performed on material 10015896 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.
Event or Problem Description
It was reported while using bd alaris pump module smartsite infusion set the tubing separated.There was no report of patient impact.The following information was provided by the initial reporter: iv tubing broke at a connection where the tubing should be sealed.The tubing was not pulled or yanked, it just fell apart.Once the disconnection was noted, the entire iv tubing was removed and bagged.There was no air in the short pigtail and the iv was easily flushed and had good blood return.New tubing was connected and the iv infusion was resumed.No need to remove or restart the iv.Event did not cause any delay in treatment or prevent a timely discharge.

• Brand Name: BD ALARIS PUMP MODULE SMARTSITE 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 ; 8448235433
• MDR Report Key: 16740562
• Report Number: 9616066-2023-00693
• Device Sequence Number: 20483021
• Product Code: FPA
• UDI-Device Identifier: 50885403234062
• UDI-Public: (01)50885403234062
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• 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): 05/22/2023

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
• Operator of Device: Other
• Device Model Number: 10015896
• Device Catalogue Number: 10015896
• 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: 03/28/2023
• Supplement Date Received by Manufacturer: 05/22/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/05/2023
• 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
• Patient Age: 48 YR
• Patient Sex: Female