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	01/28/2021
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 serum phosphate level was as low as 1.7 (hypophosphatemia).There were no other diagnostic procedures performed.It did not result to the patient being hospitalized and the patient was not treated with an additional continuous renal replacement therapy (crrt) session.It did not have mechanical ventilation added or settings adjusted, there was no treatment with extra corporeal membrane oxygenation (ecmo) initiated or adjusted, it was not treated with blood products administration.There was no blood loss.Sodium phosphate bolus was administered.There were no other actions taken in response to the event.The patient's status at the time of the event was recovered.It was later reported that the machine was preforming as expected.The ordering prescription was what was influencing the electrolytes most.The patient is deceased and it was unrelated to the device.

• 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: 11570932
• Report Number: 1000312731-2021-00005
• Device Sequence Number: 4139277
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2021

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: 01/16/2022
• Device Model Number: MD042
• Device Catalogue Number: MD042
• Device Lot Number: L120070041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/25/2021
• 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: Other
• Patient Weight: 5