InjuryKPO
MEDICALYTE
Received Jun 3, 2025 · Event occurred May 19, 2025
Report 1528807-2025-00039 · MDR key 22134119
Device
Generic name
Bicarbonate Concentrate Solution For Dialysis
Manufacturer
Nipro Renal Solutions Usa CorporationModel number
BC+201Lot number
N5A026
Product problems
- Device Contaminated During Manufacture or Shipping
- Device Contaminated During Manufacture or Shipping
Patient
NA · Unknown
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
A TREATMENT WAS COMPLETED ON A PATIENT AND WHEN STAFF STARTED TO REMOVE THE BOTTLES, CONTAMINATION WAS DISCOVERED. IT LOOKS LIKE MOLD. STAFF INSPECTED THE REMAINING BOTTLES IN THEIR AREA AND FOUND ANOTHER BOTTLE THAT HAD WHAT LOOKED LIKE MOLD FORMING AS WELL. PATIENT OUTCOME UNKNOWN. CULTURE OF THE SUBSTANCE IN THE JUG CAME BACK AS GRAM POSITIVE RODS
Remedial action
- Recall