Prismaflex 7.XXRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07332414117702), received between Jan 9, 2020 and Feb 11, 2021 — classified as 2 deaths, 1 injury, 1 malfunction.

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

3 FDA recall records name this device's identifier, 1 still open.

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-1831-2020 · Root cause: Under Investigation by firm · FDA record ↗

3. Oct 4, 2019Open, Classified

   Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.

   Z-0279-2020 · Root cause: Software design · 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.

• MalfunctionFeb 11, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT DURING TREATMENT WITH A PRISMAFLEX MACHINE, THE DEVICE HAD A MISSING BLOOD PUMP CRANK. IT WAS REPORTED THAT BLOOD WAS NOT RETURNED TO THE PATIENT A TOTAL OF THREE TIMES. THE AMOUNT OF BLOOD LOSS WAS NOT REPORTED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11315064 ↗
• InjuryApr 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A ¿SELF-TEST FAILURE, CODE 4¿ ALARM WAS TRIGGERED TWICE AND A TRANSMEMBRANE PRESSURE WAS OBSERVED TO INCREASE DURING CONTINUOUS VENO-VENOUS HEMODIAFILTRATION WITH A PRISMAFLEX CONTROL UNIT AND A PRISMAFLEX SET. TROUBLESHOOTING WAS UNSUCCESSFUL AND THE TREATMENT WAS ENDED WITHOUT THE EXTRACORPOREAL BLOOD BEING RETURNED TO THE PATIENT. AS A RESULT, THE PATIENT NEEDED AN EMERGENCY INTUBATION. THE PATIENT OUTCOME WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Blood Loss

  MAUDE report 9981157 ↗
• DeathMar 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY, A PATIENT PASSED AWAY WHILE CONNECTED TO A PRISMAFLEX CONTROL UNIT. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Death

  MAUDE report 9889236 ↗
• DeathJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT), THE PATIENT ¿CODED¿ AND PASSED AWAY WHILE CONNECTED TO A PRISMAFLEX CONTROL UNIT. THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE PROVIDED REGARDING PATIENT TREATMENT OR MEDICAL INTERVENTIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cardiopulmonary Arrest; Death

  MAUDE report 9569459 ↗

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