MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,03,05 report with the FDA on 2012-07-18 for TOF WATCH manufactured by Organon Ireland Limited.
[2732947]
Dysfunction led to an inappropriate attitude: prolonged ventilation and sedation, delay of decurarization [product quality issue], prolonged ventilation and sedation, delay of decurarization [sedation]. Case description: literature report: gerci p, et al; prolonged residual paralysis after a single intubating dose of rocuronium/an unexpected case; 2012; 1-3. This literature marketed report originating from (b)(4) as received from a health care professional refers to a (b)(6) female pt with type 2 diabetes, retinopathy, neuropathy, dialysed terminal chronic renal failure, antero-apico-septal necrosis, paroxysmal atrial fibrillation, metrorrhagia and anticoagulation. The pt's medical history included arterial hypertension, lower limbs obliterating arteriopathy, femoral and popliteal angioplasty, bilateral carotid stenosis and ischemic cardiopathy. The info involved one pt and devices involved is not available. Other suspect therapies included rocuronium bromide (rocuronium bromide). Concomitant medication included phytonadione (phytonadione). On an unk date, the pt experienced prolonged ventilation and sedation, delay of decurarization (intervention required and medically significant). The pt was hospitalized in emergency for metrorrhagia in a context of hypocoagulation related to avk treatment. Three erythrocyte packs transfusion was performed and human prothrombin complex 10 iu/kg was administered. As hemorrhage persisted and hemodynamic status fluctuated (100/58 mmhg), a uterine curettage under general anesthesia was performed. Quick induction with etomidate 0. 3 mg/kg and rocuronium 0. 9 mg/kg was performed taking into account the presence of hyperkalaemia at 5. 8 mmol/l. A curarization monitoring with tof watch was set up with stimulation of left ulnar nerve (intensity of 50 ma, interval 30s). Anesthesia was maintained with desflurane and remifentanil. A hemostatic curettage was efficiently performed within 20 minutes. At the end of the procedure, tof remained 0/4, ptc at 0 was supervised and anesthesia was maintained. Sugammadex was not administered, an expectative attitude was chosen because of renal failure: spontaneous regression of neuromuscular blockade and antagonisation of rocuronium by an association of prostigmine 40 ug/kg and atropine 15 ug/kg at two responses out of four of tof. Forty minutes after injection of rocuronium, a response appeared to tof (1/4). Two hours and half later, still only one response to tof, whereas tympanic temperature was normal (36 c) and intensity of stimulation had been increased to 60 ma. Stimulation electrodes were placed on controlateral forearm. Immediately, a ratio t4/t1 at 60% was recorded allowing the administration of antagonisation and stop of hypnotics. T4/t1 ratio evolved to more than 90% and the pt was extubated. Post-operative f/u was without particularity. Different possible causes of prolonged curarization were discussed. Both forearms ultrasound did not show any anomaly of both ulnar nerves. The electro neuromyogram performed in this pt with electrodes on surface (near stimulation by tof-watch) confirmed the existence of severe, bilateral mixed, axonal demyelinating neuropathy with sensitive predominance. A discrete assymetria was noticed, but insufficient to explain the problem. The case illustrated finally an error of interpretation of tof, probably due to a technical problem. This dysfunction led to an inappropriate attitude: prolonged ventilation and sedation, delay of decurarization. Interpretation of erroneous biological data or electronic signal may have serious consequences. The outcome of prolonged residual paralysis and dysfunction led to an inappropriate attitude is unk. The device neuromuscular transmission monitor (tof watch) itself was not available for investigation. For device neuromuscular transmission monitor (tof watch), lot number is not available and serial number is not available. For device neuromuscular transmission monitor (tof watch), quality investigation status: although the device itself was unavailable and no batch/lot no was reported a quality investigation was performed. A copy of the published article is attached as further documentation of the pt's experience. A copy of the english translation will be provided when available. Add'l info has been requested.
Patient Sequence No: 1, Text Type: D, B5
[10112920]
Report source literature description: journal: ann fr anesth reanim, author: p guerci et al, title: prolonged residual paralysis after a single intubating dose of rocuronium/an unexpected case, year: 2012.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002807818-2012-00001 |
| MDR Report Key | 2681406 |
| Report Source | 00,01,03,05 |
| Date Received | 2012-07-18 |
| Date of Report | 2012-07-05 |
| Date Mfgr Received | 2012-07-05 |
| Date Added to Maude | 2012-11-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | PO BOX 4 |
| Manufacturer City | WEST POINT PA 194860004 |
| Manufacturer Country | US |
| Manufacturer Postal | 194860004 |
| Manufacturer Phone | 2156527905 |
| Manufacturer G1 | MERCK & CO, INC |
| Manufacturer Street | PO BOX 4 |
| Manufacturer City | WEST POINT PA 19486000 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19486 0004 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOF WATCH |
| Generic Name | STIMULATOR, NERVE, PERIPHERAL, ELECTRIC (KOI) |
| Product Code | KOI |
| Date Received | 2012-07-18 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ORGANON IRELAND LIMITED |
| Manufacturer Address | SWORDS CO, DUBLIN EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2012-07-18 |