MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. MAXPLUS POSITIVE PRESSURE CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number MP1000-C

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Hemolysis (1886)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint of resistance when drawing 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 mp1000-c 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.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 maxplus positive pressure connector had issues with hemolysis in the blood sample.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "there is resistant when we draw back and a light whistling sound at times"."it was not a specific lot number.We felt it was those type of bd caps.Our hemolysis incidences seemed to increase when we started using them.When you draw back it actually whistles".

• Brand Name: MAXPLUS POSITIVE PRESSURE CONNECTOR
• 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: 11593783
• MDR Text Key: 243175643
• Report Number: 9616066-2021-50619
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403223226
• UDI-Public: 50885403223226
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072542
• 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: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MP1000-C
• Device Catalogue Number: MP1000-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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