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

Device Problems Complete Blockage (1094); Restricted Flow rate (1248)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2020

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11092652
• MDR Text Key: 225253814
• Report Number: 9616066-2020-20685
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236679
• UDI-Public: 10885403236679
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1