MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-03-30 for ESOPHAGEAL COOLING DEVICE ECD01-A manufactured by Advanced Cooling Therapy, Inc..
[71274276]
The facility was not able to provide a lot number of the suspect device because the packaging was discarded. Act has reviewed shipping records to this facility for the past 6 months and found two possible lot numbers (199110916b or 199120816). The expiration date for lot #199110916b is 2018-07-28 and the expiration date for lot #199120816 is 2018-09-22. Both lots were manufactured prior to the compliance date for fda's udi rule and do not have udis associated with them. Act has reviewed the dhr for both lots. Both lots were manufactured to specification and no deviations or nonconformaces were discovered during the manufacture and quality release of these lot numbers. Act has requested the suspect device from the end user facility and to date, has not received it from the facility. Upon receipt of the device, we will continue our investigation and provide a follow-up once we have determined the root cause.
Patient Sequence No: 1, Text Type: N, H10
[71274277]
The patient was a male, status post cardiac arrest at his dialysis center, prior to the initiation of hemodialysis. Initial rhythm was ventricular fibrillation. Advanced cardiac life support was initiated, and the patient was transported to the hospital. After resuscitation and return of spontaneous circulation, the patient was initiated on a hypothermia protocol utilizing the esophageal cooling device (ecd) on the evening of (b)(6) 2017. The 2l of water were added to the external heat exchanger prior to initiation of treatment at 6:30pm on (b)(6) 2017 to ensure it was full. A covidien kangaroo feeding tube with iris technology was placed via stylet while the ecd was in place sometime between 10:00pm and 11:59pm on (b)(6) 2017. At 2:00pm (b)(6) 2017, the external heat exchanger gave a low water alarm and an additional 2l of water was added to the external heat exchanger. The ecd was not examined for leaks or damage at this time. At 3:00pm (b)(6) 2017, the low water alarm returned, and the patient was noted to have abdominal distention. The ecd was connected to wall suction and approximately 1l of fluid was returned. The external heat exchanger was then shut off. The ecd was removed from the patient and a leak was discovered in the device. It was noted that the patient's sodium level had decreased from 138 meq/l upon arrival on (b)(6) 2017 to 128 meq/l at 2:00pm (b)(6) 2017, and subsequently 122 meq/l at 4:00pm (b)(6) 2017, at which point the patient's neurologic status was felt to deteriorate. An infusion of 3% sodium chloride was administered, and a ct scan of the brain was ordered. The patient's sodium levels increased towards normal range over the following eight hours, and the patient was noted to begin responding to commands. The patient returned to baseline neurologic status and fully recovered from his cardiac arrest.
Patient Sequence No: 1, Text Type: D, B5
[74722681]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3010412492-2017-00001 |
| MDR Report Key | 6446574 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-03-30 |
| Date of Report | 2017-05-03 |
| Date of Event | 2017-03-01 |
| Date Mfgr Received | 2017-03-01 |
| Date Added to Maude | 2017-03-30 |
| 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 | DR. ERIK KULSTAD |
| Manufacturer Street | 3440 S. DEARBORN ST. #215-SOUTH |
| Manufacturer City | CHICAGO IL 60616 |
| Manufacturer Country | US |
| Manufacturer Postal | 60616 |
| Manufacturer Phone | 8885344873 |
| Manufacturer G1 | ADVANCED COOLING THERAPY, INC. |
| Manufacturer Street | 3440 S. DEARBORN ST. #215-SOUTH |
| Manufacturer City | CHICAGO IL 60616 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60616 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ESOPHAGEAL COOLING DEVICE |
| Generic Name | ESOPHAGEAL THERMAL REGULATION DEVICE |
| Product Code | PLA |
| Date Received | 2017-03-30 |
| Returned To Mfg | 2017-04-04 |
| Model Number | ECD01-A |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED COOLING THERAPY, INC. |
| Manufacturer Address | 3440 S. DEARBORN ST. #215-SOUTH CHICAGO IL 60616 US 60616 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Other; 3. Required No Informationntervention | 2017-03-30 |