MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06,07 report with the FDA on 2014-09-19 for HMS PLUS FRENCH 30517 manufactured by Perfusion Systems.
[4714137]
Medtronic received information reporting that during use of this hms plus in a procedure, the coagulation test results did not meet the user's expectations due to the appearance of clots in the pericardium. The act (activated clotting time) results were thought to be inaccurate and unreliable. Use of the instrument was continued with no resulting patient impact. It was reported that the patient died 12 days later from respiratory complications which were not linked with this event. The instrument was inspected by medtronic france service and remains in use. Additional information has been requested. The details of the event were summarized as follows: o t=0 normal coagulation injection of 15000 ui heparin o 16min act =489sec o 39 min act=999 sec o 80 min: appearance of clots in the pericardium, the oxygenator (non-medtronic) was removed due to clots in the device that restricted the device. O 85 min act=335 sec o injection of 10000ui heparin o anti-coagulation was reversed at the end of the procedure by protamine without any problem. O patient died 12 days later from respiratory complications not linked with the event o problem: the results given by the instrument seemed to not be reliable to the customer. O patient history: aortic disease, atrial fibrillation, temporary ischemia, hypercholesterolemia, aortic valve bioprosthesis procedure.
Patient Sequence No: 1, Text Type: D, B5
[12354245]
Event investigation remains in progress and the instrument remains with the customer in the field. However, preliminary analysis performed in the field showed that the device performed as intended. There were no product issues or malfunctions detected that would have impacted this event. Device information has been requested. If additional information is received a supplemental report will be filed. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[15997095]
Patient Sequence No: 1, Text Type: D, B5
[16210451]
This supplemental report is submitted in order to correct the initial report from a reportable serious injury to a non-reportable event. Evaluation of this product event indicates that the device did not cause or contribute to a death or serious injury. Information received from the field indicates that there was no patient harm as a result of this product event. The patient died 12 days following the event and the surgeon involved with the case stated that the patient died due to a respiratory infection and the death was not related to this product event. Additionally, evaluation of the device event data showed that the device performed as expected, indicating no malfunction. Additionally, a review of prior events indicates that, for this product or similar product, the product event is not suspected to have been a cause, or contributory cause, of any previous incidents that have led to death or serious injury. Based on the information above, medtronic concluded that this device did not cause or contribute to a death or serious injury and the likelihood of the event causing or contributing to a death or serious injury if it were to recur is remote. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2014-00071 |
| MDR Report Key | 4100444 |
| Report Source | 00,01,06,07 |
| Date Received | 2014-09-19 |
| Date of Report | 2014-09-24 |
| Date of Event | 2014-02-14 |
| Date Mfgr Received | 2014-09-24 |
| Date Added to Maude | 2014-09-19 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC STRUCTURAL HEART |
| Manufacturer Street | 8200 CORAL SEA STREET NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HMS PLUS FRENCH |
| Generic Name | ANALYZER, HEPARIN, AUTOMATED |
| Product Code | JOX |
| Date Received | 2014-09-19 |
| Model Number | 30517 |
| Catalog Number | 30517 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR BROOKLYN PARK MN 55428 US 55428 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2014-09-19 |