MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7-IN PRESSURE RATED SET W/ MAXPLUS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MP5305-C
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter also notified the fda on (date) via medwatch # mw5096890.(b)(4).Investigation summary: one sample was returned for investigation.An investigation was performed.Sample was connected to a bd syringe and attempted to flush water through the set.Set was able to be primed.The customer complaint that the maxplus extension set would not flush after multiple attempts could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for model mp5305-c, lot number 20055016 was performed.The search showed that a total of (b)(4).There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the 7-in pressure rated set w/ maxplus was clogged/blocked/occluded.The following information was provided by the initial reporter: complaint 2 of 2: material #: mp5305-c , batch/ lot #: 20055016.Multiple attempts were made to flush through buff cap on end of extension set (with various from same lot number) and were unable.Had to change buff cap and able to flush and infuse ivf.

• Brand Name: 7-IN PRESSURE RATED SET W/ MAXPLUS
• 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: 11092652
• Report Number: 9616066-2020-20685
• Device Sequence Number: 3608575
• Product Code: FPA
• UDI-Device Identifier: 10885403236679
• UDI-Public: 10885403236679
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• 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
• Report Date (Section B): 12/17/2020

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 Expiration Date: 05/01/2025
• Device Catalogue Number: MP5305-C
• Device Lot Number: 20055016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2020
• Initial Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1