PulsetRecalls & reported problems across all models

We found 3 models of Pulset by Westmed, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Apr 6, 2023 and Aug 9, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Pulset recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Sep 8, 2022Terminated

   The kits are being recalled due to a lack of sterility of a spare needle contained within the kits. There is a potential for skin infection or sepsis if the patient is exposed to a non-sterilized, unused needle.

   Z-1779-2022 · Root cause: Process control · Recall details · FDA record ↗

Most reported Pulset problems

Pulset models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Pulset 3373-91

  Arterial Blood Sampling Kit
  1 recall0 reports
• Pulset 3302

  Arterial Blood Sampling Kit
  3 reports
• Pulset 3302-91VT

  Arterial Blood Sampling Kit
  1 report

Recent Pulset adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionAug 9, 2024Break; Break

  WHEN PURGING AND REMOVING THE CAP THE TIP BROKE DOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955614 ↗
• MalfunctionAug 9, 2024Break; Material Fragmentation; Break; Material Fragmentation

  THE NEEDLE WAS BROKEN COMPLETELY AT THE ARTERIAL PUNCTURE SITE WHEN REMOVING THE ABG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955510 ↗
• MalfunctionAug 9, 2024Fluid/Blood Leak; Infusion or Flow Problem; Fluid/Blood Leak; Infusion or Flow Problem

  SOME OF THE BLOOD OVERFLOWS FROM THE SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19955343 ↗
• MalfunctionApr 6, 2023Mechanical Problem; Mechanical Problem

  TIP OF THE CAP BROKE OFF AFTER THE PURGE OF THE SYRINGE. THIS HAS CAUSED A DATEX ISSUE WHERE A USER HAS BEEN COVERED IN BLOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16696606 ↗