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

Model Number	2434-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set leaked from the tpn tubing and filter.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "upon 0500 assessment of picc line, tpn tubing was reported to be leaking by the patient.Tpn filter noted to be intermittently leaking small amounts.".
Event or Problem Description
It was reported that the bd alaris¿ pump module smartsite¿ infusion set leaked from the tpn tubing and filter.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "upon 0500 assessment of picc line, tpn tubing was reported to be leaking by the patient.Tpn filter noted to be intermittently leaking small amounts.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d4: medical device lot #: 20096376 d4: medical device expiration date: 2023-09-11 h4: device manufacture date: 2020-09-10 h6: investigation summary 2 samples were received and tested by our quality team.The sets were visually inspected for possible defects but none were noticed.An infusion of saline solution was then ran through the sets and the leaks from filters became apparent.This verified the customer's complaint of leakage.These filters were then sent to the supplier in the uk for further investigation into the possible root cause.Their investigation was as such: in conclusion, the reported leakage was observed within filter 1 and due to the visual appearance has been caused during the manufacturing process, corrective actions have been implemented to eliminate any potential partial coupons by changes to the vent membrane vision system and a replacement of the waste membrane take up roller, the implicated filters have been deemed to be most likely manufactured prior to the corrective actions taking place within production.The breached bar seal on filter number 2 has been unable to determine the root cause but has most likely been caused due to pressure being applied to the filter in the incorrect direction.Due to corrective actions being taken within production for the reported defect there will be no further actions taken at this time.See h10.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12586903
• Report Number: 9616066-2021-52181
• Device Sequence Number: 3695387
• Product Code: FPA
• UDI-Device Identifier: 37613203019690
• UDI-Public: 37613203019690
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/18/2022

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: 09/11/2023
• Device Model Number: 2434-0007
• Device Catalogue Number: 2434-0007
• Device Lot Number: 20096376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2020
• 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 Sex: Unknown