INOVENT (DELVER SYSTEM)
Report
- Report Number
- 2112667-2014-00102
- Event Type
- Injury
- Date Received
- August 28, 2014
- Date of Event
- July 27, 2014
- Report Date
- July 30, 2014
- Manufacturer
- DATEX-OHMEDA/GE HEATLCARE
- Product Code
- MRN
- PMA / PMN Number
- K000186
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THIS INITIAL SPONTANEOUS DEVICE REPORT WAS RECEIVED BY PANGAS (B)(4) OF THE LINDE GROUP ON (B)(4) 2014. A HOSPITAL REPRESENTATIVE IN (B)(6) REPORTED THAT THERE WAS AN INTERRUPTION IN INHALED NITRIC OXIDE (INO) DELIVERY VIA INOVENT (B)(4) WHILE IN USE ON A PATIENT, AND THAT THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND MEAN ARTERIAL PRESSURE (MAP) DECREASED. (COMPLAINT (B)(4)). THE 11-INOVENT (B)(4) IS UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITHIN 30 DAYS OF COMPLETION OF INVESTIGATION.
ABRUPT INTERRUPTION OF INOMAX DELIVERY (DEVICE ISSUE). CARDIOVASCULAR COLLAPSE (CIRCULATORY COLLAPSE). CASE DESCRIPTION: THIS INITIAL POST-MARKETING SPONTANEOUS DEVICE REPORT WAS RECEIVED BY PANGAS (B)(4) OF THE LINDE GROUP ON (B)(6) 2014. A HEALTHCARE PROFESSIONAL IN (B)(6) REPORTED THAT THERE WAS AN INTERRUPTION OF INHALED NITRIC OXIDE (INO) DELIVERY VIA INOVENT (B)(4) WHILE IN USE ON A PATIENT, AND THAT THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE AND MEAN ARTERIAL PRESSURE (MAP) DECREASED. ON (B)(6) 2014 AT 22:00 CENTRAL EUROPEAN TIME (CET), A CRITICALLY ILL (B)(6) WAS STARTED ON INO VIA INOVENT (B)(4) FOR AN OFF-LABEL USE (NOS). AT 23:30 CET ON (B)(6) 2014, THE NITRIC OXIDE (NO) CYLINDER SHOWED A LITTLE LESS THAN "1000" AND AT 01:45 CET ON (B)(6) 2014, 3 DAYS AFTER INITIATION OF INO THERAPY, THERE WAS SUDDEN DROP IN INO DOWN TO "0" WITHOUT ANY WARNING. INOVENT (B)(4) SHOWED "CYLINDER EMPTY" AND INO DELIVERY WAS INTERRUPTED "EVEN THOUGH THE CYLINDER WAS NOT EMPTY". THE ABRUPT INTERRUPTION OF INO DELIVERY RESULTED IN HEMODYNAMIC INSTABILITY, DECREASED MEAN ARTERIAL PRESSURE AND CARDIOVASCULAR COLLAPSE; AND CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED. THE CYLINDER WAS CHANGED BY THE HOSPITAL STAFF AND AT APPROXIMATELY 02:00 CET THE PATIENT RESUMED THERAPY WITH INO VIA INOVENT (B)(4). THE PT DID NOT RECEIVE INO DURING CPR. THERE WERE NO FURTHER EXPLICIT COMPLAINTS OF A MALFUNCTION AND INO THERAPY WAS CONTINUED UNTIL THE PATIENT'S DEATH ON (B)(6) 2014. NO DETAILS WERE PROVIDED REGARDING THE PATIENT'S DEATH. THE ATTENDING PHYSICIAN CONSIDERED THE SERIOUS ADVERSE EVENT OF CARDIOVASCULAR COLLAPSE TO BE POSSIBLY RELATED TO THE DEVICE ISSUE AND RESULTANT ABRUPT INTERRUPTION OF INO DELIVERY. THE ATTENDING PHYSICIAN "SEES NO LINK BETWEEN THE ALARM" (DEVICE ISSUE) "AND THE DEATH OF THE PATIENT" TWO DAYS AFTER REPORTED DEVICE "ISSUE". THE PATIENT WAS DESCRIBED TO HAVE BEEN "IN A CRITICAL SITUATION INDEPENDENT OF THIS EVENT". LINDE HEALTHCARE HAS REQUESTED THAT THE DEVICE INOVENT (B)(4) AND NITRIC OXIDE CYLINDER (CYLINDER#21810/BATCH#CH-14-0072) BE RETURNED FOR INVESTIGATION. CASE COMMENT: ON (B)(6) 2014: THE REPORTER ASSESSED THE EVENT CARDIOVASCULAR COLLAPSE THAT OCCURRED AS POSSIBLY RELATED TO THE NO DELIVERY DEVICE. BASED ON THE TOTALITY OF INFORMATION AVAILABLE, THE COMPANY AGREES THE EVENT IS POSSIBLY RELATED TO THE ABRUPT INTERRUPTION OF INO THERAPY PRESUMABLY DUE TO THE REPORTED DELIVERY DEVICE ISSUE. THE PATIENT DIED 2 DAYS AFTER THIS EVENT, HOWEVER, THE REPORTER DID NOT BELIEVE THE DEATH WAS RELATED TO THE CARDIOVASCULAR COLLAPSE THAT OCCURRED 2 DAYS PRIOR; THE COMPANY AGREES WITH THIS ASSESSMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 526492 | INOVENT (DELVER SYSTEM) | APPARATUS, NITRIC OXIDE DELIVERY | MRN | DATEX-OHMEDA/GE HEATLCARE | 1605-9201-000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Life Threatening |