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Infusomat recallZ-2384-2024 · B. Braun Medical, Inc. · initiated Jun 17, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from B. Braun Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

FDA root cause category: Process control

What the company is doing

B. Braun Medical Inc. (BBMI) is issuing a voluntary Urgent Medical Device Correction letter via US Postal Service Certified Mail with registered return receipt on 6/17/24. Letter states reason for recall, health risk and action to take: Corrective actions are being implemented to prevent these concerns in future manufacturing lots through optimization of the disks that provide the sealing function within these valves. Until such time as lots with these corrective actions are available, users are asked to follow the "Interim Measures for Users." A follow-up communication will be provided to users when lots with these corrective actions are in place and the interim measures can be stopped. At this time, we anticipate that corrected sets may become available 04 2024, but more definitive information will be provided in our follow-up notice. Interim Measures for Users: 1. Until further notice, when administering secondary medications via piggyback please clamp the primary line above the upper Y site using the available slide clamp on the pump administration set. This will require unclamping of the primary line after delivery of the secondary medication. The instructions for this differ depending on the type of pump and software as outlined below : a. Attachment 1 provides workflow recommendations for lnfusomat Space Pumps with "U" software versions. b. Attachment 2 provides workflow recommendations for lnfusomat Space Pumps with "G" software versions and "L" (Canada only) software versions. c. Attachment 3 provides workflow recommendations for Outlook ES Pumps. Note: This does not change workflows for rates of infusion greater than 300 ml/hr for lnfusomat Pump Administration Sets and 125 ml/hr with Outlook Pump Administration sets where clamping of the primary infusion line is always required per the product IFU to prevent concurrent flow. 2. Inform all users and post the applicable attachment(s) in care areas where secondary infusions may be administered and where pu

Recall details

Recall number
Z-2384-2024
Status
Open, Classified
Initiated by the company
Jun 17, 2024
Posted by the FDA
Jul 17, 2024
Recalling firm
B. Braun Medical, Inc.
Quantity
2160 units
Product code
FPA
FDA submissions
K142036
Distribution
Worldwide distribution - US Nationwide and the country of Canada.

Product description

Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362432

Code information (models, lots, serial numbers)

UDI-DI 04046964182679; All Lots Distributed After 02AUG2023.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 94823).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page