MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2015-11-23 for ABVISER INTRA-ABDOMINAL PRESSURE (IAP) MONITORING SYSTEM ABV301 manufactured by Convatec.
[31978262]
Based on the available information, this event is deemed a reportable malfunction. No further information was available at the time of the report. Should additional information become available, a follow-up report will be submitted. Expiration date: 09/2016. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[31978263]
It was reported the patient was admitted with a diagnosis of acute pancreatitis, bilateral pleural effusion, acute kidney failure with intra-abdominal hypertension symptoms. The clinicians began monitoring the patient's intra-abdominal pressure via an abviser autovalve iap monitoring device. The healthcare professionals continued with the clinical management and performed a thoracocentesis to improve the patient's respiratory pattern. For three days, the abviser was functioning correctly, and high values of iap were observed. On the final day of use, the patient did not eliminate (urine) "during the shift" and expressed severe abdominal pain. In addition, there appeared to be "a lot of sediment within the urine collection system. " the system was disconnected and the patient eliminated 1300cc of urine. The abviser was removed and replaced. When the autovalve of the old abviser was inspected by the facility, the membrane was reported "inflated" and was "blocking the system's vent. " no further patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[33117319]
Additional information: saline solution 0. 9% was the type of infusion fluid that was used by the clinician to operate the device. It was 4 hours in between shift when the device was known to be operating properly and when the nurse found the autovalve not functioning properly. No further information was available at the time of the report. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[35762138]
Additional information: six months of historical batch records which were manufactured from the beginning of april 2015 to the end of september, 2015, were reviewed and all showed that all samples subjected to the operational timing test for the autovalve met the specification for operational timing of 90 seconds (-30 seconds to + 90 seconds). With the autovalve discarded by the end user, it was not available for physical analysis to determine the potential root cause. From the examination of the photo, history and complaint description, the potential reason was that the autovalve may have been occluded. No previous investigations are available. After review of the returned and detailed six month batch review, no discrepancies were found. There is not enough information to conclude the product did not meet specification and perform as intended. Product monitoring reviews will monitor for product trends if this issue were to reoccur. No further actions are required, and the complaint will be closed. 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
[76990442]
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 | 1049092-2015-00672 |
| MDR Report Key | 5243710 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2015-11-23 |
| Date of Report | 2015-11-03 |
| Date of Event | 2015-11-02 |
| Date Mfgr Received | 2017-05-11 |
| Device Manufacturer Date | 2013-09-18 |
| Date Added to Maude | 2015-11-23 |
| 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 | DIRECTOR, QUALITY COMPLAINT HANDLING UNIT, 7900 TRIAD CTR |
| Manufacturer City | DR., STE 400 GREENSBORO, NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Manufacturer G1 | CONVATEC, INC. |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABVISER INTRA-ABDOMINAL PRESSURE (IAP) MONITORING SYSTEM |
| Generic Name | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Product Code | FEN |
| Date Received | 2015-11-23 |
| Model Number | ABV301 |
| Lot Number | 130932 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 211 AMERICAN AVENUE GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-23 |