MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-05-04 for EXTRAVASCULAR BLOOD FLOW PROBE manufactured by Deltex Medical Limited.
[19185667]
Reported incident: deltex medical was made aware of this potential adverse event following a telephone call from (b)(6) ((b)(6) hospital) to our (b)(4) (deltex medical ltd. ) on (b)(b)(6) 2011, however, it was later determined the incident occurred prior to this on (b)(6) 2011. The incident relates to a patient who underwent bladder operation and post operatively readmitted following complications at which time a deltex medical ltd esophageal doppler probe inserted to fluid optimise the patient. Circumstances of the incident: a (b)(6) male, was admitted to (b)(6) hospital for bladder surgery. The patient was of average weight and height and underwent surgery on (b)(6) 2011. The anesthetist was (b)(6). Consultant anaesthetist. The procedure was unremarkable with no significant resistance to insertion noted and following the procedure the patient returned home. Due to complications, the patient had returned to hospital and readmitted for surgery to repair a perforation of the bladder. At that time, questions were asked as to whether the surgical devices used during the procedure had caused the perforation and it was concluded they had not. Patient condition postoperatively: during readmission on (b)(6), dr. (b)(6) inserted a naso-gastric (ng) tube to aspirate gastric contents of the stomach and the position was confirmed by the surgeon. The esophageal doppler probe (exact probe variant and batch could not be determined) was then inserted to fluid optimise the patient without any problems encountered and the esophageal doppler probe and naso-gastric tube remained in the patient post operatively for monitoring in icu as planned. The patient's condition improved over the next two days. On (b)(6) the patient continued to recover well on icu to the point where staff were lightening sedation and planning to extubate. The patient then pulled out the endo-tracheal tube but was unable to maintain breathing unaided and so was re-intubated and ventilated. During this time, the patient's naso-gastric tube became dislodged and so another fine bore 12 french ng tube was inserted. It was after this episode on (b)(6) that the patient's condition began to deteriorate requiring inotropes. Later when the patient was examined, the ng feeding solutions were discovered in the abdominal cavity. Following a ct scan of the esophagus by the surgeon, a perforation was found to be the cause of the feeding tube leak. Post operatively, the patient became septic and his condition deteriorated making his prognosis life threatening. Five drains were placed in his abdominal cavity to drain bodily fluids and as of (b)(6) 2011, the patient remains intubated and ventilated but in a stable condition in icu. Deltex medical comments: it was confirmed that only the esophageal doppler probe and naso-gastric tube were present in the esophagus during the patient's hospital stay and no other devices were inserted into the esophagus. At the time of the incident, no internal incident report form had been completed and none of the equipment or details of the equipment used including the ng tube and esophageal doppler probe were recorded; therefore, the probe variant involved in this incident could not be determined and an investigation of the device performed. Dr. (b)(6) has previously received training on the use of the cardioq and cardioq-odm on a number of occasions over the last few years. This training was on patients in the operating theatre from (b)(4) ((b)(4), deltex medical ltd. ). Discussion between the (b)(4) and dr. (b)(6) indicate the patient anatomical state could have lead to the increased risk of membrane perforation such as the bladder and esophagus.
Patient Sequence No: 1, Text Type: D, B5
[19449879]
Summary: it is apparent that the reported use of the esophageal doppler probe was uneventful and at the time of use there was no reason to conclude that esophageal perforation had occurred. At no time was any significant resistance encountered which would have suggested concern that the probe had punctured the oesophageal wall. .
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680933-2011-00009 |
| MDR Report Key | 2192459 |
| Report Source | 05 |
| Date Received | 2011-05-04 |
| Date of Report | 2011-04-28 |
| Date of Event | 2011-03-26 |
| Date Facility Aware | 2011-03-26 |
| Report Date | 2011-04-28 |
| Date Mfgr Received | 2011-04-07 |
| Date Added to Maude | 2011-08-09 |
| 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 RD. |
| Manufacturer City | CHICHESTER, WEST SUSSEX PO198TX |
| Manufacturer Country | UK |
| Manufacturer Postal | PO19 8TX |
| Manufacturer Phone | 243774837 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | EXTRAVASCULAR BLOOD FLOW PROBE |
| Product Code | DPT |
| Date Received | 2011-05-04 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DELTEX MEDICAL LIMITED |
| Manufacturer Address | TERMINUS RD. CHICHESTER, WEST SUSSEX PO198TX UK PO19 8TX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening | 2011-05-04 |