MalfunctionKPO
MEDICALYTE
Received Jun 3, 2025 · Event occurred May 31, 2025
Report 1528807-2025-00040 · MDR key 22134120
Device
Generic name
Bicarbonate Concentrate Solution For Dialysis
Manufacturer
Nipro Renal Solutions Usa CorporationModel number
BC+201Lot number
N4M013
Product problems
- Device Contaminated During Manufacture or Shipping
- Device Contaminated During Manufacture or Shipping
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
SAMPLES TESTED POSITIVE FOR CLADOSPORIUM SPHAEROSPERMUM AND RHODOTORULA MUCILAGINOSA.
Description of Event or Problem
DARK COLORED DEBRIS MOVING AROUND UNOPENED BICARBONATE SOLUTION WHILE PREPARING FOR DIALYSIS TREATMENT. SOLUTION WITH DEBRIS WAS NOT USED FOR PATIENT TREATMENT AND REMAINING SOLUTION FROM THE SAME LOT WAS CHECKED AND NO OTHER BOTTLE WAS FOUND TO HAVE DEBRIS.
Remedial action
- Recall