MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GRA SET 60DP 2SS W/EXT SET 4G-4W STPCK; INTRAVASCULAR ADMINISTRATION SET

Model Number	10050187
Medical Device Problem Codes	Complete Blockage (1094); Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
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 gra set 60dp 2ss w/ext set  4g-4w stpck had flow issues that allowed medication to enter the intravenous fluid bag.The following information was provided by the initial reporter: "the product in question is mfg # (b)(4) and has been removed from the cardiothoracic operating rooms and preop due to concerns with the tubing allowing medication making it into the intravenous fluid bag.".
Additional Manufacturer Narrative
H.6.Investigation: no product or photo was returned by the customer.It was reported that the tubing set is allowing medication into the intravenous fluid bag.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 10050187 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.
Event or Problem Description
It was reported that the gra set 60dp 2ss w/ext set  4g-4w stpck had flow issues that allowed medication to enter the intravenous fluid bag.The following information was provided by the initial reporter: "the product in question is mfg # 10050187 and has been removed from the cardiothoracic operating rooms and preop due to concerns with the tubing allowing medication making it into the intravenous fluid bag.".

• Brand Name: GRA SET 60DP 2SS W/EXT SET 4G-4W STPCK
• 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: 11467364
• Report Number: 9616066-2021-50437
• Device Sequence Number: 14403232
• Product Code: FPA
• UDI-Device Identifier: 50885403234116
• UDI-Public: 50885403234116
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/02/2021

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 Model Number: 10050187
• Device Catalogue Number: 10050187
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/02/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1