MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-07-03 for CT EXPRES 3D CONTRAST MEDIA INJECTIO SYSTEM 650207 manufactured by Bracco Injeering S.a..
[4828990]
Narrative: case received from a radiology technician through bracco (b)(4). On (b)(6) 2014 and forwarded to quintiles ls (operating on behalf of bracco) on the same day. A health care professional reports: a female patient of unknown age and with unknown medical history underwent a ct scan with contrast media injection for an unknown indication on (b)(6) 2014. Ct expres injector was used to inject contrast agent niopam 300 (iopamidol, lot no and exp date unknown). A dose of 80ml was programmed on the injector, but 146ml were injected into the patient by the injector. No further information was (b)(6) 2014: additional information was received through the previously reporting sources and through bracco injeneering on (b)(6) 2014 and was included in this follow-up report: the patient did not experience any untoward effect in association with the reported occurrence. Serial number (b)(4) has been provided for the ct express unit used for the patient. Preliminary investigation results have been received and included into the report. Further information is expected. (b)(6) 2014: update for correction was performed upon the request of bracco imaging spa by quintiles ls. The total dose which was injected into the patient by the injector was changed to 140ml (prev. 146ml). Further information has been requested. Worldwide case id: (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[12350642]
Chronology since notification by customer: - (b)(4) 2014: bracco (b)(4) was notified of the first 2 events by the customer. - (b)(6) 2014: bracco (b)(4) was notified of the third event by the customer. - (b)(6) 2014: bracco injeneering was notified of the three events by bracco (b)(4). The software logbook was not sent as requested at this time. - (b)(4) 2014: bracco informed binj that suspected over-deliveries were estimated by the customer by visual sight of the bottle. - (b)(4) 2014: 2 of the 3 d vices were received at bracco injeneering. The software logbooks could now be accessed and investigation and tests were performed. The devices were observed to be working within specification. The event as described by the customer could not be reproduced. - (b)(4), 2014: both bracco (b)(4) and bracco injeneering were informed of the fourth event customer. Both decided to visit the customer's site. Note: meddev report to (b)(4) was not deemed necessary because no harm or hazard to patient was indicated. -(b)(4) 2014: the over-deliveries were reproduced with customer at the customer site. The reproduction of events was confirmed on ct expres 3d system. Nor root cause or volume of the over-delivery was known at this time. -(b)(4) 2014: root cause identified. Preliminary software logbook investigation summary on over-delivery encountered by each patient can be closely estimated: -patient 1: programmed cm volume was 80 ml, programmed saline post-flush volume was 60 ml, total cm volume effectively delivered was 140 ml -patient 2: programmed cm volume was 85 ml, programmed saline post-flush volume was 28 ml, total cm volume effectively delivered was 113 ml - patient 3: programmed cm volume was 80 ml, programmed saline post-flush volume was 60 ml, total cm volume effectively delivered was 140 ml - patient 4: programmed cm volume was 75 ml, programmed saline post-flush vol-ume was 16 ml, total cm volume effectively delivered was 91 ml a bracco contrast media injection medical expert has determined whether the level of over-delivery could cause potential injury, serious patient injury, or death based on the data. The results are: - volumes of contrast agent administered in the reported cases of over-delivery were above or close to the maximum recommended dosage (looml) for ct indication in the current smpc of niopam 300 - the doses were within the maximum dosage described in the company cds commonly used worldwide - no safety issues are foreseen in the patients who received doses of niopam 300 in the range of 91-140 ml, unless particular clinical conditions such as impaired renal function (egfr less than 45 ml/min/1. 73 m2) or cardiac diseases are present and are known to increase the risk of adverse events. Investigation and tests led to the conclusion that the sequence and conditions on the ct expres 3d system to perform as in the adverse event is the following: hand switch connected to the ct expres 3d system test injection performed hand-switch used to start the test injection proceeding with this precise sequence of actions does not necessarily induce the device malfunction. Instead, over-delivery may be observed but is not systematic. The occurrence rate has been observed to be (b)(4) when this specific sequence is applied. Risk assessment: a full risk assessment to determine the likelihood of occurrence of death or serious deterioration in state of health (as per chapter 5. 1. 3. 6 of meddev 2. 12-1 rev 8 guidance). - extremely low use of hand switch (accessory) in hospitals (0 in ch, 0 in fr, few in (b)(4), few in other (b)(4) that represents a low percentage of sales) - specific combination of test injection + hand switch (50%) - low probability of occurrences in such configuration (<30%) - maximal mean volume of saline post-flush (30 ml) is normally much lower in comparison to the exceptional 60 ml at (b)(6) hospital. The programmed saline post-flush will determine the level of over-delivery. - limited safety risk as determined by medical expert report result/conclusion of the investigation: please find full manufacturer investigation text in field manufacturer's preliminary comments (initial/follow-up report) corrective actions: the following voluntary corrective and preventive actions to be performed: first action retrieve hand switches in hospitals - where used removal of hand switch from future shipments until software release is available second action new software release in (b)(4) available in all new shipments third action software upgrade during scheduled preventive maintenance company comments: conclusion: the risk of a death or serious deterioration in state of health has been determined highly unlikely. Although no death or serious deterioration in state of health occurred (as per chapter 5. 1. 3. 6 of meddev 2. 12-1 rev 8), bracco injeneering has decided to notify (b)(4) of these 4 incidents and conduct voluntary corrective and preventive actions.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004753774-2014-00003 |
| MDR Report Key | 4088324 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-07-03 |
| Date of Report | 2014-02-11 |
| Date of Event | 2014-02-11 |
| Date Mfgr Received | 2014-02-25 |
| Device Manufacturer Date | 2013-02-18 |
| Date Added to Maude | 2014-09-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ALBERT PINAL |
| Manufacturer Street | AVENUE DE SEVELIN 46 |
| Manufacturer City | LAUSANNE VAUD CH 1004 |
| Manufacturer Country | SZ |
| Manufacturer Postal | CH 1004 |
| Manufacturer Phone | 162117400 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CT EXPRES 3D CONTRAST MEDIA INJECTIO SYSTEM |
| Generic Name | INJECTOR |
| Product Code | IZQ |
| Date Received | 2014-07-03 |
| Model Number | 650207 |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRACCO INJEERING S.A. |
| Manufacturer Address | AVENUE DE SEVELIN 46 LAUSANNE 1004 SZ 1004 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-03 |