MAUDE Adverse Event Report: C. R. BARD, INC. BARD LUBRI-SIL I. C. TEMPERATURE SENSING FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number PK7645767

Device Problems Insufficient Cooling (1130); Incorrect, Inadequate or Imprecise Result or Readings (1535); Temperature Problem (3022)

Patient Problems Death (1802); Fever (1858); Hemorrhage, Cerebral (1889)

Event Date 12/15/2018

Event Type  Death  

Event Description

Pt dx'd w/ intraparenchymal hemorrhage and on arctic sun device w/ temperature sensing foley probe.Probe malfunctioned indicating pt hypothermic instead of febrile, and pt not properly cooled.Hot water had been instilled by arctic sun device instead of cold water.(arctic sun displayed temp as 97.5 but pt felt hotter.Foley changed and temp displayed as 106.51).Iced nml saline, iv tylenol, and antibiotics administered.Pt thereafter pronounced brain dead on (b)(6) 2018 at 5:50 pm.

• Brand Name: BARD LUBRI-SIL I. C. TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 8257316
• MDR Text Key: 133512258
• Report Number: MW5083206
• Device Sequence Number: 2
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/31/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: PK7645767
• Device Lot Number: NGCU2079
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Life Threatening; Required Intervention; Disability
• Patient Age: 43 YR