MAUDE Adverse Event Report: AIRGAS THERAPEUTICS LLC ISPAN PERFLUOROPROPANE (C3F8) GAS; INTRAOCULAR GAS

Catalog Number 8065797105

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

A physician reported that during pars plana vitrectomies with retinal detachment surgery, an ophthalmic gas was being dispensed to patients and gas bubbles in the eye were being absorbed at a faster rate than normal in multiple post operative patients.Issue was not resolved even after changing gas bottles and syringes.An ophthalmic system did not accurately dispense the volume of undiluted gas claimed to have been dispensed in the prompt due to an issue with the purge steps of the gas dispensing process.The procedure was completed with no report of patient harm.

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).

Manufacturer Narrative

The product under investigation is not a serviceable device.Therefore, a service record review was not performed.The sample was not returned.Therefore, testing could not be performed.A non-conformance-based review of the lot number was performed and did not reveal any potential contributing factors to the reported complaint.A manufacturing device history record (dhr) review was performed prior to product release to ensure that the product was manufactured in compliance with the device master record.Based on the assessment, the product met release criteria.A review for complaints reported against this lot number was performed.No similar complaints were reported for the product lot under investigation.A check of the batch production record could not be done because no lot number was reported.A check of complaint records for the lot could not be done because no lot number was reported.A check of confirmed complaints for bubbles/gas being absorbed faster than expected showed none since the beginning of 2017.The sample was not returned.Therefore, testing could not be performed.Based upon the information provided, the root cause of the reported event cannot be determined.Based upon the information provided, the root cause of the reported event cannot be determined.Manufacturer will continue to monitor data for evidence of adverse trending and take further action, as appropriate.The manufacturer internal reference number is: (b)(4).

• Brand Name: ISPAN PERFLUOROPROPANE (C3F8) GAS
• Type of Device: INTRAOCULAR GAS
• Manufacturer (Section D): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer (Section G): AIRGAS THERAPEUTICS LLC; 6141 easton road; p.o. box 310; plumsteadville PA 18949
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 18474231
• MDR Text Key: 332781792
• Report Number: 2518435-2024-00002
• Device Sequence Number: 1
• Product Code: LPO
• UDI-Device Identifier: 00380657971053
• UDI-Public: 00380657971053
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P900066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065797105
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONSTELLATION VISION SYSTEM