MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE; INTRAVASCULAR ADMINISTRATION SET

Model Number MPX5301-C

Device Problems Material Separation (1562); Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter: address unavailable.Bd (b)(6) address used.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that maxplus pressure rated extension set with needleless connector and y-site had the components separate.The following information was provided by the initial reporter: "we are having issues with this extension set pulling apart while connected to the iv pump line.".

Event Description

It was reported that maxplus pressure rated extension set with needleless connector and y-site had the components separate.The following information was provided by the initial reporter: "we are having issues with this extension set pulling apart while connected to the iv pump line".

Manufacturer Narrative

H6: investigation summary: no product or photo was returned by the customer.The customer complaint of extension sets pulling apart when connected to iv line 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 mpx5301 because a valid lot number was not provided by the customer.The root cause of this failure could not be identified without a failure investigation.H3 other text : see h10.

• Brand Name: MAXPLUS PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR AND Y-SITE
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12694078
• MDR Text Key: 278359574
• Report Number: 9616066-2021-52304
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403237223
• UDI-Public: 50885403237223
• 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,Followup
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MPX5301-C
• Device Catalogue Number: MPX5301-C
• Device Lot Number: 21065785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2021
• 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