Infusomat Administration Sets as listed below: 362031 Infusomat Space Pump Set with Caresite Injection Site; 362032 15 d

FDA device recall Z-0355-2024 · posted 2023-12-01 · Open, Classified

Recall details

Recalling firm

B. Braun Medical, Inc.

Reason for recall

In affected products, the tubing outer diameter may vary in size or the length of tubing may be too short. Both issues may lead to false air-in-line alarms, which will stop the infusion and interrupt therapy. Interruptions or delays in medication administration may result in serious injury to patients which may be life-threatening (e.g. interruption of a vasopressor to a hemodynamically unstable patient) or may lead to death.

Action taken

On November 1, 2023, the firm notified customers via URGENT MEDICAL DEVICE CORRECTION letters. Customers were informed that administration sets with lot number 0061902124 and higher were manufactured with revised specifications which should reduce the potential for false air-in-line alarms. After November 30, 2023, all lots distributed by BBMI will have been manufactured with these revised specifications. The firm provided interim measures for users to apply for affected product. For example, users should not use tubing with noticeably smaller outer diameter or which needs to be stretched to fit within the pump. If possible, unaffected lots of product should be diverted to areas that infuse high risk medications or other infusions with acute clinical effects due to initial limited supply of the new administration sets. Affected lots should be diverted to care areas that do not infuse high risk medications or other infusions with acute clinical effects. When infusing high risk medications or infusions with acute clinical effects, customers were advised to have a second pump with an administration set available for exchange in the event of a false alarm. If a second pump is not available, have a second administration set available for exchange in the event of a a false alarm. Additional patient monitoring is required. Adverse reactions or quality problems experienced with this product, or questions about this correction may be reported to BBMI s Postmarket Surveillance Department by calling 1-833-425-1464.

Root cause

Process control

Status

Open, Classified

Product code

FPA

Quantity affected

33,820,976 units

Distribution

Distribution US nationwide, Canada and Germany.

Date initiated

2023-11-01

Date posted

2023-12-01

Location

Allentown, PA

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