ISPAN PERFLUOROPROPANE (C3F8) GAS
Report
- Report Number
- 1610287-2022-00025
- Event Type
- Injury
- Date Received
- May 7, 2022
- Date of Event
- March 31, 2022
- Report Date
- October 8, 2024
- Manufacturer
- AIRGAS THERAPEUTICS LLC
- Product Code
- LPO
- UDI-DI
- 00380657971022
- PMA / PMN Number
- P900066
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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).
THE GAS TANK WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE BATCH PRODUCTION RECORD FOR LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A REVIEW OF THE COMPLAINT RECORDS SHOWED FOUR OTHER COMPLAINTS AGAINST LOTS. A REVIEW OF CONFIRMED COMPLAINTS FOR MACULAR FISSURES OR RETINAL DETACHMENT SHOWED NO COMPLAINTS SINCE THE BEGINNING . THE ROOT CAUSE CANNOT BE DETERMINED CONCLUSIVELY. 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).
PATIENT CODES (2050, 1866, 2047, 2049, 2523, 2140) ARE INCORRECTLY SUBMITTED IN INITIAL REPORTS. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
A CHECK OF THE BATCH PRODUCTION RECORD FOR THIS LOT SHOWED NO UNUSUAL MANUFACTURING ISSUES. A CHECK OF THE COMPLAINT RECORDS SHOWED FOUR OTHER COMPLAINTS AGAINST LOT. A CHECK OF CONFIRMED COMPLAINTS FOR MACULAR FISSURES OR RETINAL DETACHMENT SHOWED NO COMPLAINTS SINCE THE BEGINNING OF 2015. THE SAMPLE WAS NOT RETURNED. TESTING COULD NOT BE PERFORMED. NO SAMPLE WAS RETURNED FOR EVALUATION. AN ANALYSIS OF THE RETAIN SAMPLE FOR THIS LOT SHOWED THAT THE PRODUCT MET ALL RELEASE CRITERIA. NOTE: THE PROCEDURE DOES NOT COMPLY WITH THE DIRECTIONS FOR USE (DFU). AT THIS TIME, 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).
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
ADDITIONAL INFORMATION WAS PROVIDED IN SECTION H.6. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
ADDITIONAL INFORMATION WAS PROVIDED IN SECTION B.3. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
A CLINICAL STUDY REPORT STATED A PATIENT ADMITTED IN HOSPITAL DUE TO SUDDEN VISION LOSS IN LEFT EYE FOR HALF A MONTH AND UNDERGO POST-APPROACH VITRECTOMY (LEFT EYE) + RETINAL DETACHMENT REPAIR WITH LASER LIGHT COAGULATION, VITREOUS CAVITY PERFLUOROPROPANE GAS INJECTION, RETINAL REDUCTION, VITREOUS GAS-LIQUID EXCHANGE TRANSFUSION, RETINAL HIATUS CRYOTHERAPY AND THE PROCEDURE WAS COMPLETED SMOOTHLY AND DISCHARGED. IN 1ST FOLLOW-UP AND PHYSICIAN NOTICED ANTERIOR CHAMBER IS DEEP, AQUEOUS HUMOR CELLS (+ - ), ROUNDED DOSSING, CLOUDY LENS, BUBBLES ARE VISIBLE ABOVE THE LEFT EYE, THE OPTIC DISC COLOR, BOUNDARIES, SMALL HOLES ARE FORMED AT THE MACULA. AND IN 2ND FOLLOW-UP AND EYE EXAMINATION REVEALED INCREASED NUCLEAR DENSITY OF LENS, A LITTLE GAS AND MACULAR FISSURES. NEXT DAY OF FOLLOW-UP PATIENT ADMITTED IN HOSPITAL DUE TO MACULAR FISSURES AND DIAGNOSED WITH 1. MACULAR FISSURE (LEFT EYE) 2. VITREOUS INCISION AFTER REMOVAL (LEFT EYE) 3. AFTER RETINAL DETACHMENT (LEFT EYE) 4. RETINAL DEGENERATION (RIGHT EYE) 5. AFTER RETINAL PHOTOCOAGULATION (RIGHT EYE) 6. NUCLEAR SENILE SELF-DISORDER (BOTH EYES) 7. REFRACTIVE ERROR (BOTH EYES). ON (B)(6) 2022 PERFORM INNER BOUNDARY MEMBRANE DISSECTION (LEFT EYE) + INTRAOCULAR LENS + VITREOUS GAS-LIQUID EXCHANGE TRANSFUSION + CATARACT PHACOEMULSIFICATION ASPIRATION, WITH INTRAOPERATIVE ADMINISTRATION OF STEROID, OPHTHALMIC ANTI-INFLAMMATORY MEDICATION. THE OPERATION WAS SMOOTH, THE POSTOPERATIVE ROUTINE TREATMENT AND NURSING CARE, THE POSTOPERATIVE RECOVERY WAS GOOD, THE SUBJECT'S CONDITION WAS STABLE, AND WAS DISCHARGED FROM THE HOSPITAL. UPON EXAMINATION UPON DISCHARGED: LEFT EYE DRESSING WRAPPED IN THE EYE, NO BLOOD EXUDATE, AND CONDITION OF RIGHT EYE UNCHANGED. DISCHARGE DIAGNOSIS WAS 1. MACULAR HIATUS (LEFT EYE) 2. AFTER VITRECTOMY (LEFT EYE) 3.RETINAL DETACHMENT POSTERIOR (LEFT EYE) 4. RETINAL DEGENERATION (RIGHT EYE) 5. AFTER RETINAL PHOTOCOAGULATION (RIGHT EYE) 6. NUCLEAR SENILE CATARACT (BOTH EYES) 7. REFRACTIVE ERROR (BOTH EYES). DISCHARGED WITH ANTIBIOTICS, STEROID, OPHTHALMIC ANTI-INFLAMMATORY MEDICATIONS.
INITIAL INFORMATION WAS INCORRECTLY SUBMITTED WITH EVENTS INFLAMMATION, PROCEDURE-RETINOPEXY, RETINAL TEAR/HOLE, RETINAL DETACHMENT, CORNEAL ENDOTHELIAL CELL LOSS, CORNEAL HAZE, VISION-DECREASED ARE NOT RELATED TO THE REPORT.
NEW INFORMATION RECEIVED INDICATING FIRST TIME THAT A MACULAR FISSURE WAS FIRST DETECTED, WHEN THE PATIENT CAME FOR REEXAMINE AT (B)(6) 2022. THE MACULA AREA WAS OBSCURED ON PREOPERATIVE EXAMINATION AND NO MH WAS SEEN DURING THE SURGERY AND LATTICE DEGENERATION WAS SEEN.
ADDITIONAL NEW INFORMATION HAS BEEN RECEIVED INDICATING BOTH MEDICAL AND SURGICAL TREATMENTS WERE GIVEN WITH PROLONGED HOSPITALIZATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1078168 | ISPAN PERFLUOROPROPANE (C3F8) GAS | INTRAOCULAR GAS | LPO | AIRGAS THERAPEUTICS LLC | NA | 034914 | 00380657971022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | Male | Required Intervention| H| O |