MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN SILICONE TEMP-SENSING CATHETER; TEMPERATURE SENSING FOLEY PROBE

Device Problems Disconnection (1171); Temperature Problem (3022)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that "rewarm started around 11pm on s/n (b)(4).The patient was 32.4c at that time.At 415am, the patient was 33.4c.The device gave a message that the probe (foley) was disconnected.They are now using an esophageal probe to the device.The water was 36.5c at that time.The target temperature was changed to 38c thinking that would speed the rewarm up.Rewarm rate set to 0.5c/hr.Pti with one arrow up.Changed the target temperature back to 37c.Suggested adding a bair hugger and watching the patient's temperature.It seems the foley probe was faulty.Called back an hour later.Patient was 33.5c an hour ago, now 33.9c.Water 32.6c.Device responding appropriately.Nurse called back at 7:30am (10 minutes later) concerned that the water is still in the 30cs.Explained that the device is attempting to maintain a controlled rewarm.If the water temperature is too high the patient will warm too quickly.".

Manufacturer Narrative

The device was not returned for evaluation.A potential failure mode could be ¿sensor wire breaks thermistor cracks or breaks¿ with a potential root cause of ¿sensor wire too weak or thermistor chip too weak¿.The lot number is unknown therefore the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bard/bd is unable to determine the associated labeling to review.

Event Description

It was reported that "rewarm started around 11pm on s/n 4105.The patient was 32.4c at that time.At 415am, the patient was 33.4c.The device gave a message that the probe (foley) was disconnected.They are now using an esophageal probe to the device.The water was 36.5c at that time.The target temperature was changed to 38c thinking that would speed the rewarm up.Rewarm rate set to 0.5c/hr.Pti with one arrow up.Changed the target temperature back to 37c.Suggested adding a bair hugger and watching the patient's temperature.It seems the foley probe was faulty.Called back an hour later.Patient was 33.5c an hour ago, now 33.9c.Water 32.6c.Device responding appropriately.Nurse called back at 7:30am (10 minutes later) concerned that the water is still in the 30cs.Explained that the device is attempting to maintain a controlled rewarm.If the water temperature is too high the patient will warm too quickly.".

• Brand Name: UNKNOWN SILICONE TEMP-SENSING CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY PROBE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9733242
• MDR Text Key: 184052209
• Report Number: 1018233-2020-01191
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/01/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 03/16/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1