MAUDE Adverse Event Report: PRO TOUCH/KINDRED CPOE DEVICE

Device Problems Communication or Transmission Problem (2896); Patient Data Problem (3197)

Patient Problems Unspecified Infection (1930); Pulmonary Edema (2020); Sepsis (2067); Respiratory Failure (2484)

Event Date 07/22/2013

Event Type  Injury  

Event Description

The pt was recovering from sepsis, acute kidney, respiratory, and heart failure.Subtle, but sudden clinical regression occurred without the traditional signs of sepsis or genitourinary infection.Urine and blood cultures were ordered.The cpoe of the ehr computer had clinical decision support (cds).The cds device automatically discontinued the urine culture and ordered a urinalysis on the doctors' two attempts to order the disease critical diagnostic tests.Approx 4 days passed and there still was not a urine culture, while the pt slipped back in to kidney failure, respiratory failure, and pulmonary edema and was placed back on the ventilator.Finally, several more days later, a urine culture was done showing >100,000 gram negative rods, that then grew out of the blood culture.The delay in diagnosis was directly a result of the cds usurping the role of doctor, countermanding tests.This cds device does not have any functional over ride to get the urine culture done.Death from the delay in diagnosing and treating sepsis was narrowly avoided.The cds device is defective in so far as it does not permit an over ride, even if in the best judgement of the physician.

• Brand Name: CPOE DEVICE
• Type of Device: CPOE DEVICE
• Manufacturer (Section D): PRO TOUCH/KINDRED; louisville KY 40202
• MDR Report Key: 3339297
• MDR Text Key: 3869009
• Report Number: MW5031738
• Device Sequence Number: 1
• Product Code: OUG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/03/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 69