MAUDE Adverse Event Report: UTAH MEDICAL PRODUCTS, INC. DIALY-NATE; CATHETER, PERITONEAL DIALYSIS, SINGLE USE

Model Number SET

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 12/07/2021

Event Type  malfunction  

Event Description

Reporting as 4th occurrence in the past 6 months involving the dialynate system.At approximately 0130, rn began to question the patient's ability to ultrafiltrate (uf) consistently throughout the shift with peritoneal dialysis (pd) flushes when patient wasn't undergoing any pd dwells.On average, patient had been uf'ing 5-15 ml every hour.Given previous instances of equipment malfunction with manual pd use recently, rn decided to perform a flush of dialysate from the buretrol chamber to the collection bag, bypassing the patient.Three separate flushes were trialed (50ml, 70ml, and 100ml, respectively) directly into the collection bag, and all three outputs resulted in 10 ml above the instilled amount (60ml, 80ml, and 110ml, respectively).This discrepancy was clearly indicative of an equipment issue, likely having to do with inaccurate stamping of the measurement grid on the collection bag chamber.As a result, patient's intake and output documentation was inaccurately being reflected on the chart.Clinically, this meant that the patient was more fluid-positive that what our documentation up to this point had showed.This is a significant patient safety issue, particularly with a 7-kilo dialysis patient whose daily intake and output continuously dictates daily therapies and clinical interventions.

Event Description

Reporting as 4th occurrence in the past 6 months involving the dialynate system.At approximately 0130, rn began to question the patient's ability to ultrafiltrate (uf) consistently throughout the shift with peritoneal dialysis (pd) flushes when patient wasn't undergoing any pd dwells.On average, patient had been uf'ing 5-15 ml every hour.Given previous instances of equipment malfunction with manual pd use recently, rn decided to perform a flush of dialysate from the buretrol chamber to the collection bag, bypassing the patient.Three separate flushes were trialed (50ml, 70ml, and 100ml, respectively) directly into the collection bag, and all three outputs resulted in 10 ml above the instilled amount (60ml, 80ml, and 110ml, respectively).This discrepancy was clearly indicative of an equipment issue, likely having to do with inaccurate stamping of the measurement grid on the collection bag chamber.As a result, patient's intake and output documentation was inaccurately being reflected on the chart.Clinically, this meant that the patient was more fluid-positive that what our documentation up to this point had showed.This is a significant patient safety issue, particularly with a 7-kilo dialysis patient whose daily intake and output continuously dictates daily therapies and clinical interventions.

• Brand Name: DIALY-NATE
• Type of Device: CATHETER, PERITONEAL DIALYSIS, SINGLE USE
• Manufacturer (Section D): UTAH MEDICAL PRODUCTS, INC.; 7043 south 300 west; midvale UT 84047
• MDR Report Key: 13591104
• MDR Text Key: 286077536
• Report Number: 13591104
• Device Sequence Number: 1
• Product Code: FKO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SET
• Device Catalogue Number: 4000537
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 210 DA
• Patient Sex: Male
• Patient Weight: 7 KG