MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP; PUMP, INFUSION, ELASTOMERI

Model Number 4540040-02

Device Problem Air/Gas in Device (4062)

Patient Problem Foreign Body Embolism (4439)

Event Type  Injury  

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.

Event Description

As reported by the user facility: "the family initiated the easypump infusion and the patient stopped breathing and face color changed to blue/purple.They stopped the pump and the patient quickly recovered.The family called their pediatrician, and the pediatrician assumed the patient had choked on something or was vomiting.The family did not want to restart the infusion, so they called ems.Ems came and restarted the easypump and completed the infusion with no issue.When it came time for the next infusion, the parents again did not want to start for fear of the event occurring again, so they took the patient to the er.I'm unclear if the er started an easypump that we prefilled and sent to the patient or if they used one of their own, but the next dose was initiated in the er.It was the er doctor that mentioned air embolism to the parents."."the patient had been in the hospital and on this medication, ceftriaxone, for a few days and had been receiving it at home via easypump for a few doses before this event occurred.The initial easypump infusion was given by our visiting nurse who educated the parents on how to initiate the remaining infusions.This event was not the first time the parents initiated an easypump infusion on the patient.The ceftriaxone was ordered every 12 hours.".The patient's mother was called on the phone today.The conversation is below: "my daughter was diagnosed with mastoiditis and in the hospital for 9 days.While she was there, she was receiving ceftriaxone to treat the infection.The last few days that she was in the hospital, the staff was teaching us how to clean, flush, and infuse her antibiotics as they knew we would be discharge to home and we would need to continue the antibiotics at home.Everything was going fine at home until the morning of her 5th home dose of the ceftriaxone.She was sitting up in her highchair coloring.She had not eaten yet that day.We did everything as normal, cleaned her picc line with alcohol, flushed with saline, connected the easypump and began the infusion, and within 7-10 seconds, my daughter said that her stomach hurt, and she started to look like she was going to vomit.She was gagging and gasping for air.Her skin turned blue and purple all over her body.With in 1 minute, she was back to normal.While the event occurred, we disconnected the easypump and called ems.While we were waiting for ems to arrive, i called our pediatrician.They told us to reconnect the easypump but do not restart the infusion until ems arrived incase it was a reaction.When ems arrived, they assessed my daughter, and everything was normal.They then finished the infusion with no issues.They left and we did not have my daughter transferred to the er.After this, we spoke the infections disease and they advised us to bring her to the er for her next dose of the ceftriaxone just incase it was a reaction to the medication.So we brought her to the er with the easypump that we had at home.They drew lab work and did an ekg, and everything was normal.They assessed the easypump before connecting and noted that there was a small amount of air between the end of the tubing and the filter.They taught us to prime that air out of the tubing before starting the infusion.They gave the next infusion with no issues and diagnosed my daughter as having an air embolism.Then we were sent home.The easypump were stored in the refrigerator at our home.I would remove them about 8 hours prior to starting the infusion to warm.The picc line was heparin locked meaning that at the end of the infusion, we would flush with saline, and then flush with heparin to help prevent clotting.We always removed any excess air from the syringes before flushing.".

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).We received one used and empty easypump ii st 100-0,5-s-us without package.The following investigations were conducted: visual inspection: the received sample was taken to a visual inspection according to test method 102002 damages.Definition of the method: damages are visible changes in the original shape or surface of products and packaging caused by mechanical forces and/or manufacturing faults.Nominal: no damage is allowed that endangers the patient, impedes the use of the part as intended (e.G.The impairment of the function of a drop sensor), endangers the assembly or function of the component, impairs the appearance of the component.Actual: damages or other faults were not detected at the sample.Functional inspection: the received used sample was taken to a functional test respectively a leak test was carried out.Therefore, the empty sample was filled up to the nominal volume of 100 ml with nacl 0.9%.After starting the pump, the pump is working immediately (solution is running) at the tested sample.Then the patient connector was closed with the original wing cap (the white clamp remains open).After 60 minutes leakages at the complete system of the received sample were not detected.We detected no leaks or air in the tube.Physical inspection: n.A.Summary and assessment: based on the conducted investigations the sample is within the specification.Therefore, the complaint is considered as not confirmed.The investigation sample was forwarded to the manufacturing site.Bmi complaint management statement:- sample receipt at bmi - complaint management, dated: 2023-05-02.Sample evaluation:- received one sample of easypump ii st 100-0,5-s-us without original packaging.The batch number on the big bottom cap of the sample was 22c19ge671.Upon received, no solution was found in the sample and the sample was not clamped.A medication label attached on its tubing indicates that the sample was used to be filled with ceftriaxone.Its filling port was closed with discofix cap, whereas its patient connector was not closed with wing cap.Refer to the picture attached in the pc notification.By filling some water into the sample, solution started to flow and no leakage was observed.The sample was investigated by bbm, kindly refer to bbm investigation statement as above.Complaint and sample to be forwarded to production for further investigation.Sample/s evaluation: received one easypump ii st 100-0,5-s-us without original packaging.Visual inspection was carried out.As received condition, small amount of solution was observed in the returned sample.The sample was clamped and wing cap was not attached with the patient connector.The batch number sticker on the big bottom cap was 22c19ge671.Refer figure 1.Figure 1: complaint sample as received condition.The returned sample was filled up to nominal volume using saline with red dye.The sample was primed and stabilized before starting the pump.Upon unclamping the pump and removing the wing cap, solution was able to flow out from the patient connector immediately without any abnormality.Air bubble was not observed in the flow restrictor nor out from the patient connector throughout the flow.Figure 2: no air bubble observed in the flow restrictor line and nor out from the patient connector.Besides, air was introduced into the pump intentionally.The same procedure was carried out to determine whether the filter in the line could eliminate the air introduced.Recordings were taken, refer table below for the snapshots taken from video clips.(refer to cir) in addition, there was no leakage nor blockage observed from the sample throughout the whole pump flow.The whole process was completed without any abnormality.Summary of root cause analysis: no air bubble was observed from the returned complaint sample.Also, there was no leakage nor blockage observed from the sample.As the reported defect could not be determined, hence, we considered this complaint as not confirmed.Cause : cause could not be determine.No leakage, blockage or air bubble observed from the returned complaint sample.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERI
• 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: 16724575
• MDR Text Key: 313135501
• Report Number: 9610825-2023-00140
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448942
• UDI-Public: (01)04046964448942
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 4540040-02
• Device Catalogue Number: 4540040-02
• Device Lot Number: 22C19GE671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 04/12/2023
• Supplement Dates Manufacturer Received: 03/24/2023
• Supplement Dates FDA Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 YR
• Patient Sex: Female