MAUDE Adverse Event Report: KIMBERLY-CLARK HEALTH CARE BALLARD 1500 HME; HEAT AND MOISTURE EXCHANGER

Model Number 153

Device Problem Sediment, Precipitate Or Deposit In Device Or Device Ingredient (3021)

Patient Problem No Information (3190)

Event Date 10/14/2014

Event Type  malfunction  

Event Description

Kimberly-clark received a report stating there was a very oily substance inside of the heat and moisture exchanger (hme) which caused a shift in the ventilator settings.The shift in the ventilator settings caused the patient to hyperventilate and the ventilator machine was exchanged for another ventilator machine.Once the clinicians changed the ventilator the shift in the ventilator settings occured once more.During the second shift in the ventilator settings the clinicians observed the substance in the heat and moisture exchanger.There was no patient injury.No additional information was provided in regards to the patient's status.

Manufacturer Narrative

(b)(4) evaluation of the returned complaint product and review of the device history record is in-progress.Upon completion of the investigation, a follow-up report will be filed.Kimberly-clark has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the kimberly-clark complaint database and identified as complaint (b)(4).

• Brand Name: BALLARD 1500 HME
• Type of Device: HEAT AND MOISTURE EXCHANGER
• Manufacturer (Section D): KIMBERLY-CLARK HEALTH CARE; 1400 holcomb bridge road; roswell GA 30076
• Manufacturer (Section G): VINCENT MEDICAL (DONG GUAN) MFG. CO., LTD.; 45-46 shabu industrial zone; qiaolong district; tangxia, 523730, dgg ; CH
• Manufacturer Contact: lisa clark ; 1400 holcomb bridge road; roswell, GA 30706 ; 7705878935
• MDR Report Key: 4219745
• MDR Text Key: 4970297
• Report Number: 1033422-2014-00029
• Device Sequence Number: 1
• Product Code: BYD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/14/2014

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
• Device Operator: Other Health Care Professional
• Device Model Number: 153
• Device Catalogue Number: 991093819
• Device Lot Number: 0205036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/14/2014
• Initial Date FDA Received: 11/03/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 21 YR
• Patient Weight: 42