MAUDE Adverse Event Report: AIR LIQUIDE ISPAN PERFLUOROPROPANE (C3F8) GAS; INTRAOCULAR GAS

Catalog Number	8065797101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intraocular Pressure Increased (1937); Ischemia (1942); Loss of Vision (2139); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A customer reported that the wrong ophthalmic gas was administered that causing blood flow to the eye to be cut off.The procedure details were not provided.Additional information was received indicating the patient underwent a surgical procedure to repair a retinal detachment in her right eye (od).It was noted that the incorrect gas was given by the staff to the surgeon.The patient experienced an elevation in her intraocular pressures prompting the surgeon to perform a drainage procedure.Currently the patient is experiencing vision loss in the od.
Additional Manufacturer Narrative
Per the contract manufacturer, a check of the batch production record could not be performed, because a valid lot number was not reported.Additionally, a check of the complaint records could not be performed, because a valid lot number was not provided.Per the contract manufacturer, the perfluoropropane ophthalmic gas was unable to be evaluated, because the sample was not returned.As no sample was returned for evaluation.And with no additional, related information provided, the customer reported event was not confirmed.Based on the information obtained, the root cause of the reported event is end user error.The root cause of the reported event is end user error.Therefore, no further actions can be pursued at this time.Quality assurance has reviewed this complaint.And will continue to monitor data for evidence of adverse trend and take further action, as appropriate.At a minimum, this will include completing reviews of complaint class report levels on a monthly basis by the product team.The manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN PERFLUOROPROPANE (C3F8) GAS
• Common Device Name: INTRAOCULAR GAS
• Manufacturer (Section D): AIR LIQUIDE; 13140 ti blvd.; dallas TX 75243
• MDR Report Key: 12233211
• Report Number: 1610287-2021-00015
• Device Sequence Number: 5403582
• Product Code: LPO
• UDI-Device Identifier: 00380657971015
• UDI-Public: 00380657971015
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P900066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 8065797101
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2021
• Supplement Date Received by Manufacturer: 10/04/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 10/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention