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Diacap® 720DH19Recalls & reported problems

B.Braun Avitum AG · Diacap® Pro 19H · Class 2

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04046964610813), received between Apr 23, 2018 and Apr 25, 2018 — classified as 2 injuries.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Chills2
  • Fever2
  • Low Blood Pressure/ Hypotension2
  • Diaphoresis1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryApr 25, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED BY THE USER FACILITY: PATIENT HAD AN ADVERSE REACTION UPON STARTING DIALYSIS WITH A DIACAP PRO 19H FILTER. IMMEDIATELY AFTER BEING CONNECTED TO THE MACHINE THE PATIENT EXPERIENCED FEVER, CHILLS, A DRIFTING AWAY FEELING, DIFFICULTY BREATHING AND A DROP IN BLOOD PRESSURE. THE TREATMENT WAS STOPPED. OXYGEN WAS ADMINISTERED TO THE PATIENT. A NORMAL SALINE BOLUS WAS INFUSED. THE BLOOD LINE AND DIALYZER WERE DISCARDED. A NEW BLOOD LINE AND A DIFFERENT DIALYZER BRAND WERE SET UP. A NEW TREATMENT WAS STARTED APPROXIMATELY 30 MINUTES LATER WITHOUT ANY INCIDENTS.

    Patient problems: Chills; Fever; Low Blood Pressure/ Hypotension

    MAUDE report 7458299 ↗
  • InjuryApr 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    AS REPORTED BY THE USER FACILITY: PATIENT HAD AN ADVERSE REACTION UPON STARTING DIALYSIS WITH A DIACAP PRO 19H FILTER. APPROXIMATELY THREE (3) MINUTES AFTER BEING CONNECTED TO THE MACHINE THE PATIENT EXPERIENCED A RACING HEART, TINGLING SENSATION TO THE JAW DIAPHORETIC, BLOOD PRESSURE DROPPED SUDDENLY AND THE PATIENT BECAME UNRESPONSIVE. THE TREATMENT WAS IMMEDIATELY DISCONTINUED. THE PATIENT WAS TREATED BY THE CODE BLUE TEAM ACCORDING TO THE HOSPITAL'S PROTOCOL. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND HAD DIALYSIS TREATMENT THE FOLLOWING DAY WITH A DIFFERENT DIALYZER BRAND WITH NO ISSUES.

    Patient problems: Chills; Diaphoresis; Fever; Low Blood Pressure/ Hypotension

    MAUDE report 7450415 ↗

Other Dialyzer, high permeability with or without sealed dialysate system devices

All Dialyzer, high permeability with or without sealed dialysate system devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.