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

Model Number	C24117
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	Hypersensitivity/Allergic reaction (1907)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 as lvp 20d low sorb had flow issues due to medication running down the tubing during the priming process and causing hypersensitivity in the patient.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "the reason i am asking for this information is that nurses have reported episodes that patients having a hypersensitivity reaction to drugs that are being run down during priming of the tubing, but based on their priming volume, it should not have reached the patient yet.I know the packaging states to fill 2/3s of the chamber with fluid.".
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.It was reported that during priming of the tubing, the flow is unregulated and reaches the patient before it should.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model c24117 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.H3 other text : see h.10.
Event or Problem Description
It was reported that the as lvp 20d low sorb had flow issues due to medication running down the tubing during the priming process and causing hypersensitivity in the patient.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter: "the reason i am asking for this information is that nurses have reported episodes that patients having a hypersensitivity reaction to drugs that are being run down during priming of the tubing, but based on their priming volume, it should not have reached the patient yet.I know the packaging states to fill 2/3s of the chamber with fluid.".

• Brand Name: AS LVP 20D LOW SORB
• 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
• MDR Report Key: 11572459
• Report Number: 9616066-2021-50567
• Device Sequence Number: 19885189
• Product Code: FPA
• UDI-Device Identifier: 50885403232372
• UDI-Public: 50885403232372
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 05/19/2021

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: Health Professional
• Device Model Number: C24117
• Device Catalogue Number: C24117
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 03/25/2021
• Supplement Report FDA Received Date: 06/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1