PRISMAFLEX 7.21Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07332414126766), received between Dec 30, 2020 and Mar 22, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

2 FDA recall records name this device's identifier.

3 other recalls cover devices cleared under the same FDA submission (K131516); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jan 28, 2021Terminated

   Variability in the performance of the tubing in the Prismaflex Control Unit ARPS (Automatic Repositioning System) Pump Assembly, may lead to alarm situations during or after a system self-test.

   Z-1279-2021 · Root cause: Process control · FDA record ↗

2. Feb 6, 2020Terminated

   Baxter is communicating safety information from the Prismaflex Operator's Manual regarding the proper use of connectors with the Prismaflex system.

   Z-1833-2020 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

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

• MalfunctionMar 22, 2022No Display/Image

  WHILE THE PATIENT WAS UNDERGOING CRRT, THE MACHINE'S SCREEN THEN TURNED ALL RED. RN UNABLE TO RETURN BLOOD. THERE WAS NO EVIDENCE OF HARM NOTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847993 ↗
• MalfunctionJan 26, 2022Break; Break

  IT WAS REPORTED DURING THE SETUP OF A PRISMAFLEX MACHINE, THE DEVICE BASE WAS OBSERVED TO BE LOOSE WHEN IT CONNECTS TO THE MAIN BODY OF THE MACHINE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13359485 ↗
• MalfunctionDec 1, 2021Protective Measures Problem; Protective Measures Problem

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY ON A PEDIATRIC PATIENT USING A PRISMAFLEX CONTROL UNIT AND FOUR (4) UNITS OF A PRISMAFLEX HF20, SELF-TEST FAILURE (4, PRESSURE POD/SENSOR ISSUE) ALARMS WERE GENERATED AND AT LEAST ONE OF THE TREATMENT WAS ENDED WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT. A BLOOD TRANSFUSION WAS PERFORMED ON THE PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12908797 ↗
• InjuryDec 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT RAPIDLY REOCCURRING "EXCESSIVE TMP" ALARMS WAS GENERATED ON A PRISMAFLEX MACHINE DURING PEDIATRIC CONTINUOUS RENAL REPLACEMENT THERAPY . TREATMENT WAS DISCONTINUED AND BEFORE THE THERAPY WAS RESTARTED, THE PATIENT BECAME BRADYCARDIC AND SEVERELY HYPOTENSIVE. RESUSCITATION FLUIDS WAS PROVIDED. THE PATIENT WAS RECOVERING IN THE INTENSIVE CARE UNIT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 11095344 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131516. One submission often covers many models, so check the product and lot details in each record.

• Z-2066-2020 · Apr 7, 2020 · Terminated
  Prismaflex Control Unit
• Z-1926-2018 · Apr 24, 2018 · Terminated
  Prismaflex 7.20 US, Product Code 955542 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilogram
• Z-1925-2018 · Apr 24, 2018 · Terminated
  Prismaflex 7.XX US, Product Code 115269 Intended Use: The Prismaflex Control Unit is intended for: " Continuous Renal Replacement Therapy (CRRT) for patients weighing 20 kilogram