Fresenius 04-9500-2Recalls & reported problems
Fresenius Medical Care Holdings, Inc. · Transducer Protectors, bulk pack · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10840861100542), received between Nov 7, 2017 and Nov 7, 2017 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).
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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Fluid/Blood Leak2
Patient problems
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 7, 2017Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
A CLINIC MANAGER FROM A HEMODIALYSIS (HD) PATIENT'S FACILITY REPORTED DURING HD TREATMENT THE TRANSDUCER PROTECTOR CAME LOOSE FROM THE DIALYSIS LINES AND EXPERIENCED BLOOD LOSS DURING THE EVENT. ADDITIONAL FOLLOW-UP REVEALED THE TRANSDUCER PROTECTOR CAME LOOSE ONE HOUR AFTER TREATMENT WAS INITIATED. THE ESTIMATED BLOOD LOSS WAS 500MLS. NO PATIENT INJURY WAS REPORTED. THE PATIENT WAS GIVEN A SALINE BOLUS AND REFUSED TO GO TO THE EMERGENCY ROOM. WHEN THE PATIENT WAS STABLE SHE WENT TO THE HOSPITAL AND HAD A HEMOGLOBIN (HGB) DRAWN AND IT WAS WITHIN NORMAL LIMITS. THE PATIENT WAS MONITORED AND HER VITAL SIGNS REMAINED STABLE. NO DEFECT OR DAMAGE WAS OBSERVED TO THE TRANSDUCER PROTECTOR OR ITS PACKAGING. THE PATIENT DID NOT COMPLETE HEMODIALYSIS TREATMENT. THE SAMPLE WAS DISCARDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7008585 ↗MalfunctionNov 7, 2017Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component
A CLINIC MANAGER FROM A HEMODIALYSIS (HD) PATIENT'S FACILITY REPORTED DURING HD TREATMENT THE TRANSDUCER PROTECTOR CAME LOOSE FROM THE DIALYSIS LINES AND EXPERIENCED BLOOD LOSS DURING THE EVENT. ADDITIONAL FOLLOW-UP REVEALED THE TRANSDUCER PROTECTOR CAME LOOSE ONE HOUR AFTER TREATMENT WAS INITIATED. THE ESTIMATED BLOOD LOSS WAS 20MLS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS MONITORED AND HER VITAL SIGNS REMAINED STABLE. NO DEFECT OR DAMAGE WAS OBSERVED TO THE TRANSDUCER PROTECTOR OR ITS PACKAGING. THE PATIENT WAS ABLE TO SUCCESSFULLY COMPLETE TREATMENT ON THE SAME MACHINE. THE SAMPLE WAS DISCARDED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7008581 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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