MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D SS 0.2M CV; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2434-0007
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that as lvp 20d ss 0.2m cv leaked.The following information was provided by the initial reporter: material no: 2434-0007 batch no: unknown.It was reported that while priming iv tubing, a leak was noted from a crack in the filter.Verbatim: (b)(6) 2021, 16:20.#2434-0007 ¿ no lot number provided.¿primed iv tubing and noted leaking from a crack in the filter.¿ ¿ item was kept and we can return to bd for investigation.Patient ¿ male, dob (b)(6).¿primed iv tubing and noted leaking from a crack in the filter.¿.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval? yes? d10: returned to manufacturer on: 2021-02-23.H6: investigation summary: customer reported a leak from a crack in the filter, and returned the affected sample.The sample was primed with water, and had a clear leak in the distal air vent membrane.There is a known issue for long term alcohol-based drugs and lipids which can lead to leaks, but the customer reported only having primed the sample with saline.The supplier for the filter will be contacted to conduct a further investigation on the root cause for the issue.The sample was sent to supplier, and they mistakenly did not investigate or report on the sample.Complaint is closed to the quality engineer's memo.A device history record review could not be performed because a valid lot number was not provided by the customer.The root cause remains unknown without the supplier investigation.
Event or Problem Description
It was reported that as lvp 20d ss 0.2m cv leaked.The following information was provided by the initial reporter: material no: 2434-0007 batch no: unknown.It was reported that while priming iv tubing, a leak was noted from a crack in the filter.Verbatim: 1.(b)(6) 2021, 16:20.2.#2434-0007 ¿ no lot number provided.3.¿primed iv tubing and noted leaking from a crack in the filter.¿ ¿ item was kept and we can return to bd for investigation.4.Patient ¿ male, dob (b)(6) 2020.¿primed iv tubing and noted leaking from a crack in the filter.¿.

• Brand Name: AS LVP 20D SS 0.2M CV
• 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 22244 ; MX 22244
• MDR Report Key: 11378632
• Report Number: 9616066-2021-50301
• Device Sequence Number: 3782033
• Product Code: FPA
• UDI-Device Identifier: 07613203019682
• UDI-Public: 07613203019682
• 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): 05/27/2021

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 Catalogue Number: 2434-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 05/27/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 MO