MAUDE Adverse Event Report: MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE; ABSORBENT, CARBON-DIOXIDE

Model Number MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

At this time, the suspect device has not been returned for evaluation.But the device history record review has been requested.However, at this time, no root cause could be determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported a leak on 8003138 medisorb¿ multi-absorber original, disposable.The mac value is over 700, and therefore too much oxygen is escaping.There was no patient harm reported in this complaint.Tests/lab data, including dates.

Manufacturer Narrative

Result of investigation: the production report review showed no deviations to the specification of the device during manufacture.All units packed passed 100% leak test and visual inspection.A review of the batch documentation for the lot lo1a-00146 and 5090720 found no issues that could be linked with damage failures on these batches.Pallet and carton for canisters clearly state that they are fragile and to handle with care.Devices are packaged in a carton that meets the vyaire drop testing specification.However, as no photographic evidence has been supplied, it was not possible to determine the cause of the failure.Corrective/preventive actions have been implemented to address the reported failure and are detailed under capa 21-013.

• Brand Name: MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Type of Device: ABSORBENT, CARBON-DIOXIDE
• MDR Report Key: 12054634
• MDR Text Key: 268095002
• Report Number: 3002807637-2021-00020
• Device Sequence Number: 1
• Product Code: CBL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MEDISORB¿ MULTI-ABSORBER ORIGINAL, DISPOSABLE
• Device Catalogue Number: 8003138
• Device Lot Number: LO1A-00146 AND 5090720
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/28/2021
• 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): Required Intervention