MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP® II; ELASTOMERIC INFUSION PUMP

Model Number N/A

Device Problem Inaccurate Delivery (2339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received 2 used (half filed) easypump ii lt 100-50-s and 2 used (nearly empty) easypump ii lt 100-50-s without packaging.The received samples were taken to a visual inspection.Damages were not detected.In as-received condition the white clamps were closed at the samples and the patient connector was not closed; the original wing caps were not handed over by the customer.Further on, we detected liquid and crystallized drug residues at the filling ports (lli-cone) and at the patient connectors (lla-cone) of the samples.The pumps were filled with nacl 0.9 % up to the nominal value (100 ml) and a functional test respectively a leak test was carried out.After waiting for 60 minutes the pumps did not work (solution was not running).Leakages were not detected at the received samples.The received samples are not within our specifications.We have informed our manufacturer accordingly.Statement: received four pieces of used, approximately partial filled of easypump ii lt 100-50-s in open packaging.Both samples were labeled as s1, s2, s 3 and s4 respectively.S1: in as received condition, clamp clip was closed and wing cap was not handed over by the customer.Big top cap was opened and filling port was closed with discofix cap.Residue of solution was not detected at the filling port.Crystallized residue was observed at the filter and housing of the patient connector.Crystallized residue also observed at the gap between glass tube and microbore tube.Stopper of the returned sample was opened, solution was not flowing.S2: since the returned sample was contaminated with cytotoxic drug (5fu), de-contamination process was carried out in order to proceed for further investigation.As received condition, clamp clip was closed and wing cap was not handed over by the customer.Big top cap was opened and filling port was closed with discofix cap.Residue of solution was not detected at the filling port.Crystallized residue was observed at the filter and housing of the patient connector.Crystallized residue also observed along the tubing of microbore tube.Stopper of the returned sample was opened, solution was not flowing.S3: since the returned sample was contaminated with cytotoxic drug (5fu), de-contamination process was carried out in order to proceed for further investigation.As received condition clamp clip was closed and original wing cap was not handed by customer.Big top cap was opened and filling port was closed with dosifix cap.Residue of solution was not detected at the filling port.Crystallized residue was observed at filter, patient connector and microbore tube.Stopper was opened and sample was left for 10 minutes, solution was not flowing.S4: since the sample was contaminated with cytotoxic drug, de-contamination process was carried out.As received condition refer figure 15, clamp clip was closed and wing cap was not handed over by the customer.Big top cap was opened and filling port was closed with dosifix cap.Residue of the solution was not observed at the filling port.Crystallized residue was observed at filter, microbore tube, patient connector and glass tube lumen.Stopper was opened left for 10 minutes, solution was not flowing.De-contamination process was carried out due to the sample was contaminated with cytotoxic drugs.Analysis : after the de-contamination process, the samples were filled with nacl to its nominal volume of 100 ml.After one hour of staging time, s2, s3 and s4 were flowing.Solution in s1 was not flowing.It could be due to the crystallized residue still stuck in the tubing caused blockage.S1: unable to proceed with water flow rate test.Investigation end.S2: proceed with water flow rate test.S3: proceed with water flow rate test.S4: proceed with water flow rate test.S2: flow rate test was carried out.Flow rate test result is failed, with mean flow rate of 1.35 ml/hr (-32.69% deviation from nominal flow rate of 2 ml/hr).No abnormally trend was observed from the flow rate pattern.Microbore sub assembly was then dissected from the returned sample and nitrogen flow rate test was performed.Result of nitrogen flow rate: 3.22 ccm within spec spec: 3.13 ~ 3.30 ccm.The slow flow rate could be possibly contributed by the less elasticity of the pump which already went thru more than one time infusion and drug was left in the pump during transferred from customer to bbm and bbm to bmi.S3: flow rate test was carried out.Flow rate test result is failed, with mean flow rate of 1.68 ml/hr (-15.78% deviation from nominal flow rate of 2 ml/hr).No abnormally trend was observed from the flow rate pattern.Microbore sub assembly was then dissected from the returned sample and nitrogen flow rate test was performed.Result of nitrogen flow rate: 3.25 ccm within spec spec: 3.13 ~ 3.30 ccm.The slow flow rate could be possibly contributed by the less elasticity of the pump which already went thru more than one time infusion and drug was left in the pump during transferred from customer to bbm and bbm to bmi.S4: flow rate test was carried out.Flow rate test result is failed.Mean flow rate is unable to be calculated due to too slow of infusion occurred extreme slow in instant flow rate was observed, at ~0.50ml/hr.Microbore sub assembly was then dissected from the returned sample and nitrogen flow rate test was performed.Result of nitrogen flow rate: 3.22 ccm within spec spec: 3.13 ~ 3.30 ccm.The slow flow rate could be possibly contributed by the less elasticity of the pump which already went thru more than one time infusion and drug was left in the pump during transferred from customer to bbm and bbm to bmi.Conclusion: the slow flow rate complaint is not judgeable.Justification: not judgeable.Reviewed the device history record and no abnormalities found during in process and final control inspection.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): problem of diffusion - partial diffusion.Drug: 5fu.

• Brand Name: EASYPUMP® II
• Type of Device: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun-str. 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: ludwig schuetz ; carl-braun-str. 1; melsungen, hessen 34212 ; GM 34212 ; 5661712769
• MDR Report Key: 5492985
• MDR Text Key: 40328547
• Report Number: 9610825-2016-00090
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/10/2016,11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 4540016
• Device Lot Number: 15B20GE261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2016
• Distributor Facility Aware Date: 03/04/2016
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/10/2016
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2015
• 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