MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG SPACESTATION; RACK SYSTEM AND ACCESSORIES FOR SPACE INFUSION PUMPS

Catalog Number 8713140

Device Problems Device Alarm System (1012); Loose or Intermittent Connection (1371); Fail-Safe Problem (2936)

Patient Problem Cardiac Arrest (1762)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility by bbm sales organization in belgium: "take over mode - connection error." according to the customer: "the take over mode between two perfusor space has been deficient with message "connection error".The patient is dead.".

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).The device has been investigated in our service department at b.Braun melsungen ag, melsungen, germany: a visual inspection for the space station was performed.The cover caps on the screw pillars were intact and undamaged.The device was slightly soiled.It was found that one tube guide was missing, and one tube guide was loosened.The lower pins of the connector f2a showed signs of corrosion.The connector f2c showed a slightly bigger clearance to the housing than the other connectors.No technical safety check sticker was attached to the housing of the station.A visual inspection for the space cover comfort was performed.The device was slightly soiled.The battery compartment door showed a small gap to the lower housing part and was fixated with tape.The locking mechanism of the battery compartment door was not completely locked (approximately in a 45-degree angle).A functional test was performed.The station was connected to the mains voltage.The contacts f2a-f2d were supplied with power and the connected test devices could be charged.A connection to the hibased program via the f3 connector could be established with pumps on all connectors.The devices operating states were forwarded to the connected space cover comfort via the f5 connector, as well as to the hibased program.The space cover comfort displayed the operating states of the devices correctly and as soon as the mains connection of the station was disconnected the battery pack of the cover supplied the cover with power.Individual inspection: according to the investigation of the cc 400594236 and cc 400594237 the tom was tested with the samples from the two complaints at all pump slots and functioned according to the specification.During the disassembling of the space station, it was found that the fixation of the f2c connector was broken off on one side.During the disassembling of the space cover comfort, it was found that the battery compartment door was damaged and already got glued before.The clearance of the locking mechanism was bigger than usual.The complaint could not be confirmed.The described error pattern could not be reproduced.During the investigation no impairment of the functions could be detected.During the investigation, the described damages on the connectors f2a and f2c showed no impact to the function of the device.According to the history analyzation of the cc 400594236 and cc 400594237 in 3 cases the infusion was stopped at the tom master.In all 3 cases, the tom slave correctly displays the message "connection lost".Stopping the infusion at the master leads to a termination of tom at the master and consequently the master does not send a tom heartbeat signal.The missing tom heartbeat signal of the master is detected by the tom slave and reported to the user with the message "connection error".Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

• Brand Name: SPACESTATION
• Type of Device: RACK SYSTEM AND ACCESSORIES FOR SPACE INFUSION PUMPS
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-strasse 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B.BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 17184052
• MDR Text Key: 317678826
• Report Number: 9610825-2023-00151
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K062699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8713140
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1