MAUDE Adverse Event Report: BELIMED AG BELIMED STEAM STERILIZER MST-H TOP 5000

Model Number GR 9-6-15 HS2

Device Problem Problem with Software Installation (3013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

During initial installation of the device at a healthcare facility, the technician in charge intended to program a prevacuum cycle based on user-specified parameters.He entered the parameters and renamed the program to identify the prevacuum cycle.However, he failed to save the changed parameters and the program reverted to the original gravity cycle parameters.Thus, whenever the supposedly prevacuum program was run, a gravity cycle was executed.The program was used occasionally from (b)(6) 2018 through (b)(6) 2019.Seven sterilizers were installed at the affected healthcare facility at the time under the supervision of the same technician.Four of the sterilizers were affected by a similar problem.This is medical device report number two of four.The programming error has been corrected and the program is running properly.Corrective and preventive actions have been initiated.

Event Description

A user-specified prevacuum sterilization cycle was incorrectly programmed by the technician during initial installation of the sterilizer.The program ran a gravity cycle with additional sterilization hold time.Device sterilization was ensured, but the error repeatedly resulted in wet packs.

• Brand Name: BELIMED STEAM STERILIZER MST-H TOP 5000
• Type of Device: STEAM STERILIZER
• Manufacturer (Section D): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer (Section G): BELIMED AG; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• Manufacturer Contact: heidi friesacher ; grienbachstrasse 11; zug, zug 6300 ; SZ 6300
• MDR Report Key: 11712805
• MDR Text Key: 250195767
• Report Number: 3001061128-2021-00005
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170228
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: GR 9-6-15 HS2
• Device Lot Number: 25178
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1