MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG INFUSOMAT®; PUMP, INFUSION

Model Number 8713050U

Device Problems Device Alarm System (1012); Pressure Problem (3012)

Patient Problems Extravasation (1842); Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Swelling/ Edema (4577)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

As reported by the user facility: on 4/26/2023 the user facility reported during bolus operation, the pump automatically adjusts the pressure occlusion setting to stage 9 due to higher rates in bolus mode.Stage 9 pressure setting is 16.5 psi (acceptable range between 11.6-20.3psi) on 5/10/2023 additional information received indicates significant extravasation occurred.Causing circulation compromise and edema which required a left forearm fasciotomy & carpal tunnel release.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).No samples were returned for evaluation,but it log review of the the unit reported was performed.Log review shoed the following: on 11/18/2023 and 8:00am a pump power-on and at 8:48am an infusion start of 100ml/hr and 900ml.At 9:30am with a volume infused of 70.95ml a bolus of 100ml was selected.At 9:35am volume infused to 170.95ml.At 9:42am with a volume infused to 182.72ml a bolus of 100ml was selected.At 9:47am volume infused to 282.73ml.At 9:52am with a volume infused to 290.0ml a bolus of 200ml was selected.At 9:58am infusion was stopped with a volume infused to 414.65ml.No further infusions took place.Based on the review of the logs issue reported was not confirmed, further investigation could not be possible sue to no physical sample.

• Brand Name: INFUSOMAT®
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16956640
• MDR Text Key: 315531287
• Report Number: 9610825-2023-00218
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 04046963716752
• UDI-Public: (01)04046963716752
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K083689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 8713050U
• Device Catalogue Number: 8713050U
• Device Lot Number: 5054214080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 11 YR
• Patient Sex: Male
• Patient Weight: 36 KG