MAUDE Adverse Event Report: GRACE DISCOVERY SCIENCES SODASORB CARBON DIOXIDE ABSORBENT; SODASORB CARBON DIOXIDE ABSORBENT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hyperthermia (1909)

Event Date 11/12/2015

Event Type  Injury  

Event Description

While prepping the pt, anesthesiologist expressed concerns about increasing etco2 levels, possible malignant hyperthermia.Malignant hyperthermia cart immediately brought in.Etco2 went from 30% to 50%.No temperature elevation noted.Foley cath draining yellow urine.Pt given 8 vials of dantrolene.Istat labs drawn sicu called report, cooling blanket.Per intensivist: except for hypercarbia, pt has no tachycardia, no muscle rigidity and no hyperthermia, and the cpk levels were normal.Suspicion for malignant hyperthermia is very less at this point.Believed upon further investigation, this may have been caused by the sodasorb filter turning to violet, then back to white without color change being noted.

• Brand Name: SODASORB CARBON DIOXIDE ABSORBENT
• Type of Device: SODASORB CARBON DIOXIDE ABSORBENT
• Manufacturer (Section D): GRACE DISCOVERY SCIENCES; columbia MD 21044
• MDR Report Key: 5384780
• MDR Text Key: 36883406
• Report Number: MW5059548
• Device Sequence Number: 1
• Product Code: CBL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2016

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 52 YR
• Patient Weight: 93