MAUDE Adverse Event Report: PLEXITRON SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number MRC0001MP

Device Problems Filling Problem (1233); Free or Unrestricted Flow (2945)

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

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that medication was being delivered to a patient at a higher rate than expected when using a plexitron solution administration set; further described as although the roller clamp is closed the intravenous fluids continue to pass in a bolus.This was identified during a patient infusion and as a result the patient received 500ml instead of the expected 100ml.The medication infused was not specified.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Correction made to a3: gender: male (previously submitted as female) correction made to e1: initial reporter phone no.: +011()3053708174 (previously submitted as +011(903)053708174) additional information was added to h4, h6, h10.H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PLEXITRON SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12288991
• MDR Text Key: 265425044
• Report Number: 1416980-2021-04843
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07707141305553
• UDI-Public: (01)07707141305553
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MRC0001MP
• Device Lot Number: SE21CC6
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2021
• Date Device Manufactured: 10/25/2020
• 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
• Treatment: UNSPECIFIED MEDICATION; UNSPECIFIED MEDICATION
• Patient Age: 68 YR