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

Model Number N/A

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We received one easypump ii lt 60-30-s in original packaging.The received sample was checked visually.At the sample the inprint at the balloon was: 60 ml and 2 ml / h.At the sample the sticker at the filter was 250 ml / h.Furthermore the sample was filled up to 270 ml and a flow test respectively a leak test was carried out.After opening the white clamp and waiting for a while, the pump is work (solution was running).Leaks were not detected.Furthermore we tested the flow rate of the received sample.Nominal: 2 ml/h actual: 160.4 ml/h after 1 h, 187.8 ml/h after 2 h, 207.5 ml/h after 3 h therefore we think it was a confusion during the production process and the 270 ml pump was reversed with a 60 ml pump.The received sample is not within our specifications.We have informed our manufacturer accordingly.Received 1 piece of used, partial filled of easypump ii lt 60-30-s with the original packaging.The information printed on the original packaging was observed.Batch number: (b)(4) article number: 4540010 product description: ii lt 60-30-s flow: 2 ml/h time: 30 h then, the physical of the returned sample was verified.Batch number pasted at bbc: (b)(4) volume pasted at bbc: 60 ml flow pasted at bbc: 2 ml/h flow rate sticker pasted at filter: 250 ml/h observed yellowish of the solution left over in the pump and filter.Physical size of the pump was compared with s size and m size pump.The size of the returned sample is m size pump while the size for article 4540010 is s size pump.Returned sample : m size pump article 4540010: s size pump as received condition, clamp clip was closed and the original wing cap was attached to the patient connector.Big top cap was opened and discofix cap was observed at the pump.After opening the white clamps, the pump did work (solution was running).Analysis: 250 ml of nacl was filled to the returned sample and water flow rate test was carried out using test spec as below.Nominal volume: 250 ml nominal flow rate: 250 ml/hr duration: 1 hour as a test result, the mean flow rate tested was 28 ml/hr.The test result was abnormal due to its flow rate was slow compare to a common 250ml pump.Tested result also not comparable with the result obtained by the investigator from bbm, 160.4 ml/hr after 1 hour of infusion.Further investigation was carried out to investigate on the slow flow rate issue.Investigation steps: dissected microbore tube from the returned sample flow rate was slow.Dissected filter from the return sample flow rate became faster.Slow flow rate could be possibly contributed by the faulty filter which has been contaminated by the "yellowish stain".Nitrogen flow rate of the dissected microbore tube was measured.Nitrogen flow rate: 118.4 ccm microbore tube length: 22.5 cm referring to the nitrogen flow rate specification for all released elastomeric pumps, the article which is matching to the nitrogen flow rate of 118.4 ccm and with 250ml/hr m size pump is article 4540048.To further confirm the yellowish stain on the filter did contribute to the slow flow rate, "yellowish-stain" filter was assembled to a new m size pump.Three pieces of new pumps with new filters were selected to be the controlled samples.Instant flow rate was extremely slow (6.68 ml in 10 minutes) compared to the instant flow rate from new filters (1400 ml in 10 mins).Thus, "yellowish-stain" filter is confirmed to be the contributor to the slow flow rate of the returned sample.It could possibly be contaminated by the "distilled water" filled by bbm investigator during first level of investigation.To continue on water flow rate testing of the returned sample, a new filter was used and microbore tube was re-attached back to the returned sample.250 ml of nacl was filled to the returned sample and water flow rate test was carried out using test spec of article 4540048.The flow rate test result for the returned sample using test spec of article 4540048 is passed.In conclusion, the returned sample is confirmed mixed from article 4540048 production batch.Corrective measures has already been initiated and are documented under capa (b)(4) justification: justified.Reviewed the device history record and no abnormalities found during in process and final control inspection.

Event Description

As reported by the user facility ((b)(4)): the sticker on the filter is "250 ml/h" instead of "2 ml/h".

• 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: 5211676
• MDR Text Key: 30802536
• Report Number: 9610825-2015-00509
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/09/2015,06/10/2015

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 Expiration Date: 11/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 4540010
• Device Lot Number: 14N18GE231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2015
• Distributor Facility Aware Date: 11/04/2015
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/09/2015
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 11/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2014
• 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