MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG BBRAUN SPACE PUMP; PUMP, INFUSION

Device Problems Failure to Power Up (1476); Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Shutdown (4019)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/27/2023

Event Type  malfunction  

Event Description

Patient had ordered and was receiving an active norepinephrine infusion being titrated at high rates between 0.1-0.3 mcg/kg/min throughout the shift.On multiple occasions throughout the shift, the infusion pumps running norepinephrine spontaneously powered off while infusing due to no determinable reason.Whenever this happened, the pump displayed error codes 2150 or 2112 and would not turn back on.Each time, this required pumps to be hurriedly replaced; tubing to be re-primed and changed quickly; new medication bags to be hung; and/or pump towers to be exchanged.Per the patient's nurse, these episodes repeated themselves 12-15 times in a 4-5 hour period.In total, ten different infusion pumps failed, were swapped out, and then sent to clinical engineering for evaluation.Three pump tower in total were used and exchanged.Tubing and medication bags were changed an estimated 5-6 times.Several times, the delay in medication, especially when it was running at the higher rates, caused the patient's blood pressure to decline fairly significantly but supplemental or additive interventions or medications were never required or initiated, aside from higher doses of norepinephrine being required to recover the patient after the infusions were resumed.These events also inhibited the nurse's ability to adequately care for a second patient, as the time commitment to intervene was exhaustive and consuming, and the nurse was also reticent to venture too far away from the patient's room at any given moment for any reason.Reference reports: mw5149933, mw5149934, mw5149935, mw5149936, mw5149938, mw5149939, mw5149940, mw5149941, mw5149942.

Event Description

Additional information received for report mw5149937 on 01/10/2024 to update serial number.

• Brand Name: BBRAUN SPACE PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 18474781
• MDR Text Key: 332544264
• Report Number: MW5149937
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/10/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PUMP TOWER; TUBING