MAUDE Adverse Event Report: BELLCO SRL HMB32; DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)

Model Number	MD042
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Electrolyte Imbalance (2196)
Date of Event	02/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the patient had a decreased potassium levels (hypokalaemia).It was said that the subject was on furosemide/lasix, which was known to affect potassium.Machine was performing as intended.The ae (adverse event) had resulted to a treatment/medication with (adjusted, added, or dose reduced) potassium chloride bolus and 2 milliequivalent (meq) of potassium chloride was added to dialysis fluid.It was said that diagnostic tests were performed such as serum potassium which was 2.2 and the poc (point-of-care) potassium which was 2.4 but there were no diagnostic procedures performed.The ae did not result in the subject of being hospitalized and the ae was not treated with an additional crrt (continuous renal replacement therapy) session, not treated with mechanical ventilation added or settings adjusted, not treated with ecmo (extracorpreal membrane oxygenation) initiated or adjusted and not treated with blood products administration.The severity of the adverse event (ae) was moderate.The issue was resolved and the patient had recovered.

• Brand Name: HMB32
• Common Device Name: DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
• Manufacturer (Section D): BELLCO SRL; v camurana 1; mirandola,mo 41037 ; IT 41037
• MDR Report Key: 11495142
• Report Number: 1000312731-2021-00002
• Device Sequence Number: 17480200
• Product Code: KPO
• UDI-Device Identifier: 38051411600061
• UDI-Public: 38051411600061
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2021
• Device Model Number: MD042
• Device Catalogue Number: MD042
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 9