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

Model Number N/A

Device Problems Inaccurate Flow Rate (1249); Insufficient Flow or Under Infusion (2182)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2019

Event Type  malfunction  

Manufacturer Narrative

B.Braun medical, inc.(importer) is submitting this report on behalf of b.Braun melsungen ag(manufacturer).This report has been identified as b.Braun melsungen ag internal report (b)(4).The device has been requested to send it for investigation to bbm laboratory in (b)(4).In the moment the device is investigate in our service laboratory.If we get new information, an investigation report will create.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): "incident with pump; underinfusion." customer information: albumin 20% infusion started at 17.30hrs, at 21.20hrs pump alarmed to say vtbi complete, pump stated 13.5mls has been infused which was the correct amount.However, still 10mls remained in the syringe.Lasix had been added to albumin solution.Phoned day shift nurse to confirm 13.5mls had been drawn up.Further information: reporter added that it's possible the 3.5 mls was infused or used to prime.

Manufacturer Narrative

This report has been identified as b.Braun melsungen ag internal report (b)(4).During the analysis of the history log files it could be detected that all data from the day of occurrence were overwritten.During the visual inspection of the perfusor space, all cover caps on the screw pillars were available and undamaged.The seal on the lower housing part were missing.No damages could be detected.The functional test was performed.The device passed the self test with a positive result.A syringe could be successfully identified and selected in the pump menu.It was possible to bring the pump in operation.The delivery accuracy of the pump was checked (rate 5ml/h).The determined value +1,27%) was within specification (+-2%) (according to en iso 60601-2-24).As further functional test an infusion mode with mains connection (with power supply sp) was started.No malfunction were found.It could not be excluded, that the error is due to defective power supply or space station of the customer.For an inside investigation the device was disassembled.It could be detected a damage of the claw mechanism and a damage of the housing of the drive head.Both damages could only happened due external forces e.G.A fall incident.The complaint could not be confirmed.Summing up all tests, the perfusor space operated within our specification.Note: this report is being filed for an item number that is not sold in the united states, however similar items are sold in the united states by b.Braun medical, inc.

• Brand Name: PERFUSOR®
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-strasse 1; melsungen, 34212 ; GM 34212
• MDR Report Key: 8769251
• MDR Text Key: 178334946
• Report Number: 9610825-2019-00243
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/08/2019,07/25/2019

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 8713030
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/25/2019
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/08/2019
• Distributor Facility Aware Date: 07/04/2019
• Device Age: 13 YR
• Date Report to Manufacturer: 07/08/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 07/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1