MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CUSTOM SPINAL ANESTHESIA TRAY; SPINAL TRAY

Catalog Number 560385

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Cardiopulmonary Arrest (1765)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.A representative from b.Braun medical inc.Is attempting to obtain additional details from the reporting facility regarding each case.The event description did indicate the patients had co-morbidities that would predispose them to these events.There is no current information available to suggest that the b.Braun kit caused or contributed to the reported events.Per the drug instruction sheets contained in the kit for the reported product catalog number, cardiac and respiratory arrest are cited as potential adverse reactions to the administration of the drug.Specifically, "high doses, or inadvertent intravascular injection, may lead to high plasma levels and related depression of the myocardium, decreased cardiac output, bradycardia, heart block, ventricular arrhythmias, and, possibly, cardiac arrest." in addition, "high doses or inadvertent intravascular injection may lead to high plasma levels and related central nervous system toxicity characterized by excitement and/or depression.Restlessness, anxiety, dizziness, tinnitus, blurred vision or tremors may occur, possibly proceeding to convulsions.However, excitement may be transient or absent, with depression being the first manifestation of an adverse reaction.This may quickly be followed by drowsiness merging into unconsciousness and respiratory arrest." furthermore, "if not treated immediately, convulsions with simultaneous hypoxia, hypercarbia, and acidosis plus myocardial depression from the direct effects of the local anesthetic may result in cardiac arrhythmias, bradycardia, asystole, ventricular fibrillation, or cardiac arrest.Respiratory abnormalities, including apnea, may occur." review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.There were no other reports of this nature against the reported lot number.The investigation into this reported event is ongoing.All available information has been forwarded to the drug manufacturer for further evaluation.Following the receipt of additional information and/or completion of the investigation a follow-up report will be filed.

Event Description

As reported by the user facility: event # 1: reports three adverse incidents in older patients undergoing total joint replacements.There was one event of cardiac arrest and one event of respiratory arrest within the past two weeks.Another event of cardiac arrest occurred on (b)(6) 2015.The patients had co-morbidities that would predispose them to these events.All patients survived and were transferred to the icu.No further information is available at this time.

• Brand Name: CUSTOM SPINAL ANESTHESIA TRAY
• Type of Device: SPINAL TRAY
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: robert hubert ; 901 marcon blvd.; allentown, PA 18109 ; 6102660500
• MDR Report Key: 5309826
• MDR Text Key: 33846325
• Report Number: 2523676-2015-00614
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/03/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 560385
• Device Lot Number: 0061449684
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2015
• 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): Life Threatening; Required Intervention