• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE ANESTHESIA CONDUCTION KIT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION, INC TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number 405672
Device Problem Defective Device (2588)
Patient Problem No Code Available (3191)
Event Date 04/15/2019
Event Type  Injury  
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. Pma / 510(k)#: enforcement discretion. Investigation summary: thirteen samples were provided for evaluation. The investigation was not able to identify or confirm any contribution for the manufacturing plant to the reported failure mode. Specific to the handling of the drugs, the investigation noted specific procedures to control the handling of any raw material drug component during the receipt, storage, and use in the manufacturing process. A review of the temperature monitoring system within the (b)(4) facility did not identify any excursions that would have negatively affected any of the raw material drug components used within this product code. The investigation did identify this failure mode as a previously known issue. Over a period of more than 10 years, no test result from samples returned due to ineffective anesthesia has ever failed to meet specifications. The causes of ineffective anesthesia have been well documented in clinical literature for many years. Whereas a strong history of testing has supported that drug potency is not the cause, the actual cause may not always be ascertained. Bd has a long history of test results to support that drug potency issues have not been the cause of ineffective anesthesia events reported to bd through the complaint system. As a preventive action, the vendor of the applicable drug component, will be notified of the reported failure mode from the customer. Likewise, the complaint will be entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis (qda) process if an adverse trend is identified. Although a lot number was not provided for this particular complaint it is suspected that the lot number may be identical to complaint (b)(4), mfr# 1625685-2019-00032, (lot # 0001275590) since both complaints were reported at the same time by the same customer. A dhr review of all applicable manufacturing records for lot 0001275590 did not identify any issues that may have contributed to the reported failure mode. Dhr review for this lot is captured under complaint (b)(4). Investigation conclusion: the investigation was not able to identify or confirm any contribution for the manufacturing plant to the reported failure mode. Root cause description: based on the complaint investigation, a probable root cause could not be identified for the reported failure mode. The investigation identified a previous capa (capa 67717) performed by the bd anesthesia quality group that specifically investigated the ¿ineffective anesthesia¿ failure mode. Refer to capa (b)(4) for additional information regarding the outcome of the investigation. Likewise, the investigation identified a summary for previously investigated complaints; which, provides rationale and information regarding the potential ineffective anesthesia outcome during the use of an anesthesia product code. Based on a review of all of these sources, the current complaint investigation could not identify a definitive root cause nor could any potential contributor be identified for this specific complaint failure mode.
 
Event Description
It was reported that change in treatment occurred with a tray spn whit25g3. 5 l/b-d/e blue drape. The following information was provided by the initial reporter. The bupivacaine did not work and the patients had to be converted to general anesthesia. For patient (b)(6). Per email: a patient was to undergo spinal anesthesia as primary anesthesia, but was still able to move their leg. Staff had to convert to general anesthesia. Similar results with multiple cases on the same day. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameTRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer (Section G)
CAREFUSION, INC
400 east foster rd
mannford OK 74044
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8608222
MDR Text Key145088178
Report Number1625685-2019-00033
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SEE H.10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number405672
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/14/2019 Patient Sequence Number: 1
-
-