MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. GEM V/NV MC 4SS 20DP 10PK DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number	10821753
Medical Device Problem Codes	Leak/Splash (1354); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 an unspecified number of gem v/nv mc 4ss 20dp 10pk dehp free experienced a missing component.The following information was provided by the initial reporter: our surgical services dept encountered an issue with the burrette set where the white clamp was missing.
Additional Manufacturer Narrative
One photo and one sample of model 10821753 burette set was received from the customer for investigation.Upon visual inspection of the received samples, and in comparison to the current assembly drawing, it was verified that the white tube clamp on the bottom of the pumping segment tubing (p/n tc10006064) is missing from the construction.The root cause was identified as a misassembly of the set during the manufacturing process.No testing was performed as the misassembly was obvious.A device history record review could not be performed on model 10821753 because a lot number was not provided by the customer.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that an unspecified number of gem v/nv mc 4ss 20dp 10pk dehp free experienced a missing component.The following information was provided by the initial reporter: our surgical services dept encountered an issue with the burrette set where the white clamp was missing.
Additional Manufacturer Narrative
The following information has been updated/corrected: b.3.Date of event: (b)(6) 2020.
Event or Problem Description
It was reported that an unspecified number of gem v/nv mc 4ss 20dp 10pk dehp free experienced a missing component.The following information was provided by the initial reporter: our surgical services dept encountered an issue with the burrette set where the white clamp was missing.

• Brand Name: GEM V/NV MC 4SS 20DP 10PK DEHP FREE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10304770
• Report Number: 9616066-2020-02269
• Device Sequence Number: 14169368
• Product Code: FPA
• UDI-Device Identifier: 37613203019195
• UDI-Public: 37613203019195
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/29/2020

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: 10821753
• Device Catalogue Number: 10821753
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 09/14/2020; 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other