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

Model Number	2200-0500
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Fda device problem code: 1354.Fda patient problem code: 2199.
Event or Problem Description
It was reported that as lvp 20d dehp leaked.The following information was provided by the initial reporter: material no: 2200-0500 batch no: 17017286 it was reported that there was an incident/s with defective alaris tubing.
Event or Problem Description
It was reported that as lvp 20d dehp leaked.The following information was provided by the initial reporter: material no: 2200-0500 batch no: 17017286.It was reported that there was an incident/s with defective alaris tubing.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/6/2021.H.6.Investigation: one sample was received for quality investigation.The customer complaint of tubing defective / damaged could not be verified upon investigation of the sample.The sample and the packaging was investigated and no defects or damages were identified.The sample was then primed and a simulated infusion was conducted at a rate of 125 ml/hr.No leaks, air-in-line or occlusions were observed during testing.A device history record review for model 2200-0500 lot number 17017286 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A root cause could not established because the failure mode could not be verified.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of tubing defective / damaged with lot #17017286 regarding item #2200-0500.H3 other text : see h.10.

• Brand Name: AS LVP 20D DEHP
• 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: 11092807
• Report Number: 9616066-2020-20688
• Device Sequence Number: 13622362
• Product Code: FPA
• UDI-Device Identifier: 37613203012646
• UDI-Public: 37613203012646
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (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): 01/26/2021

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: 01/24/2020
• Device Model Number: 2200-0500
• Device Catalogue Number: 2200-0500
• Device Lot Number: 17017286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Initial Date Received by Manufacturer: 12/01/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1