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U.S. Department of Health and Human Services

Class 1 Device Recall somat Space Infusion System/ Large Volume Pump

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 Class 1 Device Recall somat Space Infusion System/ Large Volume Pumpsee related information
Date Initiated by FirmAugust 07, 2024
Date PostedSeptember 07, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2972-2024
Recall Event ID 95093
510(K)NumberK191910 
Product Classification Pump, infusion - Product Code FRN
ProductInfusomat Space Infusion System/ Large Volume Pump, Product Code 8713050U
Code Information UDI-DI (GUDID) - 04046963716752 Serial Numbers 52226, 107529, 123259, 123815, 123843, 139003, 147678, 147721, 147725, 239018, 239165, 239231, 239279, 339337
Recalling Firm/
Manufacturer		 B Braun Medical Inc
200 Boulder Dr
Breinigsville PA 18031-1532
For Additional Information ContactJonathan Severino
610-266-0500
Manufacturer Reason
for Recall		Extension of previous recall RES 92978. Pumps have the potential for upstream occlusion sensor to cease proper function due to buildup of electrostatic charge during operation triggering false downstream and upstream occlusion alarms. Additional devices have been affected.
FDA Determined
Cause 2		Component design/selection
ActionOn August 7, 2024, the firm notified customers via "URGENT MEDICAL DEVICE CORRECTION" letters which specified that previous recall RES 92978 had been extended to include additional serial numbers as well as one additional model number. The updated serial numbers for the prior models has been documented under RES 92978. This present record documents the addition of model number 8713050U. Customers were instructed to identify affected units in their facilities and to place the provided stickers on impacted units to aid clinical and biomedical staff in identifying units which require sensor exchange and application of interim control measures described in the letter. The firm recommends that consignees use non-impacted devices for the delivery of high-risk medications, and do not use impacted serial numbers for high-risk medications until the upstream occlusion sensor can be replaced. Return the product correction acknowledgement for to B.Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to PA_QualityAssurance.BBMUS_Service@bbraunusa.com even if the total inventory in your possession is zero (0). A Field Service Representative will contact customers to arrange for a time and date to check their pump and replace their impacted sensors. If you have any questions, contact us at 610-266-0500.
Quantity in Commerce14
DistributionUS distribution to AL, CA, GA, IL, MI, and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
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