MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION OASIS PEDIATRIC DRAIN; APPARATUS, AUTOTRANSFUSION

Model Number 3612-100

Device Problem Calibration Problem (2890)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/21/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted upon the completion of the investigation into this event.

Event Description

Nurse reported that over the weekend she could not turn up the suction dial from -20cmh2o up to -30cmh2o.There was no impact to the patient and another drain was attached which worked correctly.

Manufacturer Narrative

Analysis - the oasis drain was removed from the packaging and inspected for any damage.No damage was found.Upon initial inspection there was some plural fluid still in the drain.The claim was that the regulator of the chest drain could not be adjusted from the pre-set value of -20cmh2o to -30cmh2o.The regulator when attempted to be turned to -30cmh2o would not move initially but was able to be adjusted past the -30cmh20 location after turning the dial back down to -10cmh20 and then back up to -30cm.The regulator was then able to be adjusted freely up to -40cmh2o.The regulator initially was not turning freely as it should.To ensure the chest drain performed properly otherwise the drain was set up per the instructions for use and the vacuum was applied to the drain at the pre-set value of -20cmh2o and the output recorded.The regulator was working properly as the recorded value under vacuum was 19.6cmh2o at the patient line.This was duplicated also at -30cmh2o.The actual output measurement was -27.4cmh20.At both settings the drain was functioning properly.To ensure the product was manufactured properly a review of the machine parameters were reviewed.The welding machine parameters indicate that the vibration welder machine responsible for the welds was set up properly.This data is documented within the finished assembly device history records.A review of the device history records show that this drain lot passed all quality and performance requirements and that there were no non-conformances noted during the production build of this lot of oasis chest drains that consisted of a total of (b)(4) units.A review of the inspection records of the raw materials used in the build of oasis chest drains was also reviewed that related to the weld of the regulator to the drain body and outer cover.All raw materials met the incoming inspection requirements and there were no non-conformances noted during the inspections.As the inventory of the affected lot has been depleted a group of 60 additional oasis pedi drains product lot number 456441 was obtained from inventory and tested to ensure the regulator on each drain was able to be rotated full scale from -10cmh2o up to -40cmh2o.All 60 units¿ regulators functioned properly without incident.The data was recorded and is attached to the complaint file.A review of the manufacturing procedures indicates that there are currently no process steps during manufacture that rotate the drain full scale from -10cmh20 to -40cmh20.To that manufacturing will be conducting an update to the vibration welder start-up procedure to ensure that the adjustable regulator can be freely adjusted to full range in both directions on oasis and express setup samples.Summary/conclusion - based on the details provided and the evaluation of the physical product atrium medical corporation has concluded that the drain in question had an area of weld surrounding the regulator that was too large that prohibited the regulator from being advanced initially but was overcome during the process of the investigation freeing the regulator.To mitigate any future risks the atrium medical corporation manufacturing engineering team is implementing a change to the set up procedure of the vibration welder production procedure that instructs the technician to test the set up samples to the full range of the regulator rotating it from -10cmh20 to -40cmh2o prior to running the manufacturing lot.

Event Description

N/a.

• Brand Name: OASIS PEDIATRIC DRAIN
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9889395
• MDR Text Key: 186753285
• Report Number: 3011175548-2020-00465
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00650862111019
• UDI-Public: 00650862111019
• Combination Product (y/n): N
• PMA/PMN Number: K043140
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2022
• Device Model Number: 3612-100
• Device Catalogue Number: 3612-100
• Device Lot Number: 452826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 3