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

Model Number	8713080U
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: the nurse claimed the pca pump inaccuracies.Said that pump alerted vial empty but there was still 9ml's left in syringe.
Additional 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.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).The actual pump involved in the reported incident was not returned to b.Braun's carrollton, tx facility for evaluation, however log history was provided and a review of them was performed.The review showed the following: log review shows on 4/10/2023 and 4:00am battery near empty alarmed with a volume infused of 51ml.At 4:30am battery alarm stopped the infusion with a volume infused of 51ml and at 4:33am pump automatically shut-off.At 5:20am pump was powered-on with battery near empty alarm and new therapy and drug library: dilaudid selected and at 5:36am a pca 1.00ml was infused.At 5:50am battery alarm stopped the infusion and at 5:53am pump automatically shut-off.At 5:58am pump was powered-on with battery empty alarm and ac was plugged-in.At 5:59am new therapy and drug library: dilaudid was selected and pump alarmed device alarm 1137.Pump power-cycle correctly and at 6:01am new therapy and drug library: dilaudid was selected and at 6:05am a pca was initiated but pressure alarm stopped the infusion with a volume infused of 0.11ml.At 7:29am a pca was initiated and pressure alarm stopped the infusion with no further volume infused.At 7:44am a pca was initiated and pressure alarm stopped the infusion with a volume infused to 0.12ml.At 8:34am a pca 1.00ml occurred for a volume infused to 1.12ml.No further infusions occurred and log shows no syringe empty alarms occurred on 4/10/2023.Log review did not conirmed any malfunction of the pump.

• Brand Name: PERFUSOR®
• Common Device Name: 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: 16885603
• Report Number: 9610825-2023-00202
• Device Sequence Number: 5956271
• Product Code: FRN
• UDI-Device Identifier: 04046963915308
• UDI-Public: (01)04046963915308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2023

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
• Operator of Device: Health Professional
• Device Model Number: 8713080U
• Device Catalogue Number: 8713080U
• Device Lot Number: 97018504E1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2023
• Supplement Date Received by Manufacturer: 04/13/2023
• Initial Report FDA Received Date: 05/08/2023
• Supplement Report FDA Received Date: 07/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown