MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-10-06 for DP6 9070-7001 manufactured by Deltex Medical Ltd.
[123844381]
This is a retrospective initial report as advised by esghelpdesk following submission of a combined final report. The investigation into this event was restricted due to the lack of information from the reported and the absence of a device to investigate. A review of batch records found no issue with the manufacture of the device in question. The user confirmed there was no issue with the design, manufacture, or quality of the device which performed as intended at the time of use and hence was discarded. Following investigations and communications with the clinicians involved it has been concluded the device was not the cause of the patient harm. The (b)(6) has also completed its investigations and concluded the device was not the cause of the patient harm. (b)(6) has closed the case. For further details of this incident and the subsequent difficulties in setting up the esg webtader account or reporting into fda, please see final report.
Patient Sequence No: 1, Text Type: N, H10
[123844382]
On (b)(6) 2017 an (b)(6) female patient underwent colorectal surgery at the (b)(6) hospital in (b)(6) during which a dp6 deltex medical ltd esophageal doppler probe was in use (it is not known if it was orally or nasally inserted). There were no complications with the device during the procedure after which the probe was discarded. Around 24 hours later the patient went for a ct scan that showed possible small perforation of the esophagus. Pneumothorax and faecal contamination were later identified in this patient although there was no indication this was related to use of the dp6 doppler probe. Patient was transferred to ward on (b)(6) with intra venus antibiotics, endoscopically placed ngt, tpn, ir chest drains and died on an unknown date afterwards as reported "into" deltex medical ltd for the first "tim" on 21 "spet" 2017 (this was a duplicate report issued in error by clinical staff as communicated on conference call by the hospital). No information regarding the use of the dp6 esophageal doppler probe device or its relationship to the clinical conditions was provided despite extensive communications via email and conference call. The hospital stated that there were no issues with the device at the time of use and that it performed as intended. There were no design, manufacturing, or quality issues with the "evice" which was discarded at the time of use.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9680933-2017-00001 |
| MDR Report Key | 7941373 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-10-06 |
| Date of Report | 2018-10-06 |
| Date of Event | 2017-08-23 |
| Date Mfgr Received | 2017-09-12 |
| Device Manufacturer Date | 2017-01-31 |
| Date Added to Maude | 2018-10-06 |
| 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 Contact | MR GRAHAM LOWE |
| Manufacturer Street | TERMINUS RD |
| Manufacturer City | CHICHESTER, WEST SUSSEX PO198TX |
| Manufacturer Country | UK |
| Manufacturer Postal | PO19 8TX |
| Manufacturer G1 | DELTEX MEDICAL LTD |
| Manufacturer Street | TERMINUS RD |
| Manufacturer City | CHICHESTER, WEST SUSSEX PO198TX |
| Manufacturer Country | UK |
| Manufacturer Postal Code | PO19 8TX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DP6 |
| Generic Name | OESOPHAGEAL DOPPLER PROBE |
| Product Code | DPT |
| Date Received | 2018-10-06 |
| Model Number | 9070-7001 |
| Catalog Number | 9070-7001 |
| Lot Number | 10307D |
| Device Expiration Date | 2018-12-31 |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DELTEX MEDICAL LTD |
| Manufacturer Address | TERMINUS RD CHICHESTER, WEST SUSSEX PO198X UK PO19 8X |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Life Threatening | 2018-10-06 |