MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DESIGN OPTIONS®; ANESTHESIA CONDUCTION KIT

Catalog Number 560580

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Incontinence (1928); Paralysis (1997)

Event Date 08/16/2016

Event Type  Injury  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the lot number, a batch record review could not be performed.No specific conclusions can be drawn.It was indicated in the event summary that multiple drug products were administered during the procedure.The reported kit catalog number contains the following drugs: 5 ml lidocaine 1%, 2 ml bupivacaine 0.75% w/ dextrose, 1 ml epinephrine 0.1%.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or involved drugs.All available information has been forwarded to the drug manufacturer.There is no current information available to suggest that the b.Braun product caused or contributed to the reported event.If additional pertinent information that impacts the result of the investigation becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports the patient had a neurotoxicity after the procedure.The patient was given an epidural spinal for a planned c-section.After the procedure, the patient had numbness and weakness bilaterally in lower extremities and bladder incontinence.The patient continues with paralysis and urinary incontinence.All tests including mri and emg were negative for a biologic cause.The facility protocol is to skin prep with chlora-prep prior to all epidurals and spinals, and not use prep in tray.Drugs given to patient were epinephrine from tray, skin wheel with lidocaine, bupivacaine, morphine, and fentanyl.Per follow-up correspondence with the reporting facility, the patient had no prior medical history, no renal diagnosis.It was determined that there were no issues with the insertion.The patient was sitting, spinal inserted midline, l3-l4, cerebrospinal fluid clear.The following events occurred post spinal insertion: 13:05-1 ml of 0.75% bupivicaine and 0.25 mg duramorph via epidural.13:15-spinal morphine given 13:20-patient became bradycardic, missed beats with intermittent premature ventricular contractions (pvc's).The patient was unable to speak, but was able to follow commands.13:30-patient went into sinus tachycardia 13:32-arterial o2 at 92%.Labs drawn, results as follows: hematocrit 29% lactic acid 0.8 k- 3.2 na- 138 ph- 7.45 pa 02- 103 co2-23 13:35-small dose of fentanyl/ephedrine given iv in which an unknown amount of time after dose the patient experienced significant hypertension, blood pressure 180/90.After an unknown amount of time, blood pressure resolved.The patient is still considered a paraplegic with unknown etiology.Referred to physical and occupational therapy.

• Brand Name: DESIGN OPTIONS®
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: bridseida melendez ; 901 marcon blvd; allentown, PA 18109 ; 6102660500
• MDR Report Key: 6118083
• MDR Text Key: 60565693
• Report Number: 2523676-2016-00804
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K813186
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 560580
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 33 YR