MAUDE Adverse Event Report: INTEGRA - PRINCETON ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE; N/A

Model Number INS8400

Device Problem Use of Incorrect Control/Treatment Settings (1126)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

A patient was transferred from icu department during hospitalization for external venticular bypass ten craniotomy following cerebrovascular accident of the posterior fossa.The medical team then detected intracranial hypertension (with hypertensive crisis) with non-permeable accudrain without the anti-reflux valve system (ins8400) system.At the end of the transfer, the system (ins8400) stayed clamped on the proximal side.During the transfer the system was clamped on proximal and distal sides.The nurse indicated they explained to paramedic team how the system functioned and how to clamp the taps.The medical team removed the drainage system the day after.At the time of this report, the patient was still in the hospital making it difficult to evaluate neurological consequences following this dysfunction.

Manufacturer Narrative

Accudrain (ins8400) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.Failure analysis - as per reported condition, it is stated that ¿during the (patient¿s) transfer the system was clamped on proximal and distal sides¿ and that ¿at the end of the transfer, the system stayed clamped on proximal side¿.Apparently, this was an oversight of the health professional who forgot to reopen/unclamp the proximal side.Product¿s instructions for use (ifu), in the "to transport patient" section, includes the following: ¿after patient transport has been completed, system use should be re-established with the correct pressure level reference relative to patient according to physician's orders.All stopcocks should be reoriented to reestablish flow.Ensure and verify flow from the patient into the burette.¿ the ifu emphasizes on the last sentence (ensure and verify flow from the patient into the burette.) by highlighting it with bold letters (also in the french¿s ifu version).At this point, it is the health professional responsibility to ensure that the system is left working as prior to transferring the patient.Root cause - based on the foregoing failure analysis, the root cause for the reported event is user related.Precautions to ensure that flow from the patient into the burette should be taken after the patient¿s transfer is completed.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

Event Description

N/a.

• Brand Name: ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA - PRINCETON; 1100 campus road; 1100 campus road; princeton NJ
• Manufacturer (Section G): INTEGRA - PRINCETON; 1100 campus road; none; princeton NJ
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 15910912
• MDR Text Key: 304789426
• Report Number: 2648988-2022-00026
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 10381780023876
• UDI-Public: 10381780023876
• Combination Product (y/n): N
• PMA/PMN Number: K042825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: INS8400
• Device Catalogue Number: INS8400
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Male