MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-06-13 for ABVISER - INTRA ABDOMINAL PRESSURE MONITOR ABV321 manufactured by Convatec, Inc..
[47269230]
Based on the available information, this event is deemed to be a serious injury. No lot number is available, a detailed investigation or batch review cannot be conducted. Therefore this evaluation will be closed. This issue will be monitored through the post market product monitoring review process. No additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[47269231]
A nurse reported that the auto valve of the abviser did not automatically reopen after taking a measurement resulting in urinary retention for the patient. The abviser was used on a patient in an intensive care unit setting beginning (b)(6) 2016 at approximately 7:30pm to monitor the patient's intra-abdominal pressures due to severe abdominal distention and firmness. The patient had biliary leakage into the peritoneal cavity for which a couple of drains had been inserted to relieve the pressure. The patient's urine was reported to be very viscous and thick throughout the use of the abviser and foley catheter. It was reported that the device was properly primed and prepped according to the information for use and working fine throughout the evening; pressure readings were between 10 and 11. At some point during the night, the catheter stopped draining and on the morning of (b)(6) 2016, after compressing the plunger and waiting, the auto valve did not automatically open or drain; the abviser was discontinued but the foley catheter was left in place. The patient began complaining of pain and an ultrasound of the bladder showed 180cc's of retained urine, due to this retention the patient had developed elevated blood pressure and required additional pain medication. The patient continued to experience discomfort and it was noted that the foley catheter was not properly draining. When a new catheter was inserted, the patient began to leak urine and a large blood clot was expelled giving the patient some immediate relief. The nurse reported that he inspected the abviser and found that the auto-valve was deflated. Additionally, he felt that the issue was not related to the abviser, but most likely was a result of the blood clot (it is unknown how long after discontinuation of the device the inspection took place). The patient has since been discharged from the hospital.
Patient Sequence No: 1, Text Type: D, B5
[48732729]
Received a used section of an adviser for evaluation. The product sample was disposed of as per procedure. Therefore, this complaint will be closed with no further actions required. No additional patient/ event details have been provided to date. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1049092-2016-00278 |
| MDR Report Key | 5721053 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-06-13 |
| Date of Report | 2016-05-20 |
| Date Mfgr Received | 2016-06-22 |
| Date Added to Maude | 2016-06-13 |
| 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 | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABVISER - INTRA ABDOMINAL PRESSURE MONITOR |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2016-06-13 |
| Returned To Mfg | 2016-06-17 |
| Model Number | ABV321 |
| Operator | NURSE |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC, INC. |
| Manufacturer Address | 211 AMERICAN AVENUE, SUITE 400 GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-13 |