MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-05-04 for DOPPLER PROBE 240 HOUR DP240 9070-7005 manufactured by Deltex Medical Ltd..
[614850]
Date of adverse incident: 2007. Reported complaint: the quality assurance & regulatory affairs manager received a call from dr (intensive care consultant) at the hospital. The call related to the perforation of the esophagus of a woman, who was admitted to the accident and emergency unit in 2007. The pt had collapsed at home and was comatose. The attending clinicians suspected that stroke was the cause, but there were no clear indications. The pt also suffered a number of fits. Dr said that the neurological assessment was inconclusive and they had little medical history available from relatives or friends to establish the history prior to the collapse. The main concern was stabilizing a very ill patient, and that the investigation into the cause of the collapse was continuing in parallel. Deltex medical device associated with adverse incident: deltex medical ltd does not at this time accept causality for the incident. Circumstances of the incident: an attempt was made to insert a nasogastric tube (ng) in the a&e dept. , but this proved problematic and an obstruction to insertion was apparent. We understand that the ng tube was left in place and subsequently on chest x-ray was not apparent in the esophagus and was thought to be coiled in the throat. On sunday evening in the icu dr. Was concerned by the patient's hypothermic condition and wished to perform fluid therapy. A deltex medical esophageal doppler probe dp240 reportedly from batch no. 5711n (we have not been provided with the used probe or packaging) was requested to be inserted. We understand that this procedure was carried out by a senior health officer who had difficulty inserting the probe and asked a nurse experienced in doppler use to continue the insertion. We understand the nurse succeeded in inserting the probe and a cardiac output signal was obtained as a precursor to managing the fluid administration. On a separate occasion, dr. Reports re-inserting the ng tube and finding obstruction at a depth of 45 to 50 cm from the nasal nares. Also at one point during the treatment, a chest x-ray was taken and the ng tube was lying in the plane of the esophagus, but dr. Explained that without a lateral view it is not possible to conclude it was definitely within the esophagus, but felt that most likely it was. We have also been advised that cardiac output measurements were still available from the cardioq monitor, which we conclude would mean that the dp240 probe was correctly located in the esophagus. Further ng tube insertion difficulties were encountered on tuesday. On wednesday, endoscopy was used to confirm the position of the ng tube and two lacerations of the esophagus were found and the ng tube was protruding through the upper laceration. The position of the lacerations is unclear to us at this time. Dr. Has advised us that the probe was discarded, but that his recollection was that there was nothing abnormal in its appearance and that there were no signs of structural damage. Patient condition: we were made aware by dr. That the pt had died. The cause of death was at the time described to us unofficially as vasopressor resistant septic shock most likely as a result of mediastinitis due to the esophageal perforation (this has been reviewed subsequently. )
Patient Sequence No: 1, Text Type: D, B5
[7961400]
We were also made aware by dr. The circumstances of the death will be subject of a coroner's enquiry, and that a post mortem will be performed. The post mortem will provide important information as to the location of the perforations and whether any underlying medical condition was responsible or contributory to the incident. We have taken steps to make it known to the coroner that we are available to assist in their investigation. At this time we are confident that as reports suggest cardiac output signals were obtained from the dp240 and cardioq monitor, that the probe was correctly located in the esophagus. Hospital senior health advisor called deltex medical marketing director by telephone. Advised us that the post mortem was now complete. The cause of death is now reported not to be related directly to septicaemia subsequent to esophageal perforation. Ulcerations were found in the oesophagus at the level of the thyroid cartilage and were described as partly healed lacerations. She advised that the hospital had reviewed the incident and had accepted that there is always a low risk of esophageal damage when inserting equipment. They had established that the nurse inserting the esophageal doppler probe was competent in this procedure. We were also advised that this was not the first admission of the patient to the hospital for her undetermined neurological condition. It is not clear to us whether the esophagus was perforated, nor is it clear when the partly healed lacerations had originally occurred. At this time we have received no formal response from the hospital as to the role if any of the dp240 oesophageal doppler probe in the patient's death. It is unclear from the reports we have received to date as to when the two areas of perforation occurred or whether these were iatrogenic i. E. Caused by insertion of devices into the laceration or the esophagus.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680933-2007-00004 |
| MDR Report Key | 854309 |
| Report Source | 05 |
| Date Received | 2007-05-04 |
| Date of Report | 2007-05-04 |
| Date of Event | 2007-03-25 |
| Date Facility Aware | 2007-03-29 |
| Report Date | 2007-05-04 |
| Date Mfgr Received | 2007-03-29 |
| Device Manufacturer Date | 2006-12-01 |
| Date Added to Maude | 2007-05-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | TERMINUS ROAD |
| Manufacturer City | CHICHSTER, WEST SUSSEX PO198TX |
| Manufacturer Country | UK |
| Manufacturer Postal | PO19 8TX |
| Manufacturer Phone | 12437748 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOPPLER PROBE 240 HOUR |
| Generic Name | DP240 |
| Product Code | DPT |
| Date Received | 2007-05-04 |
| Model Number | DP240 |
| Catalog Number | 9070-7005 |
| Lot Number | 5711N |
| ID Number | NA |
| Device Expiration Date | 2009-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 102 DAY |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 839994 |
| Manufacturer | DELTEX MEDICAL LTD. |
| Manufacturer Address | TERMINUS ROAD CHICHESTER, WEST SUSSEX UK PO19 8TX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2007-05-04 |