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

Model Number N/A

Device Problem Inaccurate Flow Rate (1249)

Patient Problem Hyperthermia (1909)

Event Date 11/22/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).We received a used (empty) easypump ii lt 270-27-s without package.The received sample was taken to a visual inspection.Damages were not detected.In as-received condition the white clamp was closed on the sample and the patient connector was not closed; the original wing cap was not handed over by the customer.The pump was filled with nacl 0.9 % up to the nominal value (270 ml).A functional test respectively a leak test was carried out.After opening the white clamp the pump did work immediately (solution was running).Leakages were not detected on the received sample.Flow rate test: nominal: 10 ml/h.Actual: 13.0 ml in 1 hrs; 26.6 ml in 2 hrs; 171.8 ml in 17 hrs.Leakages were not detected at the received sample.A fast flow (as described by the customer) could not be determined.Hence we assess this complaint to be not justified.We have informed our manufacturer accordingly.Reviewed the device history record and no abnormalities found during in-process or final control inspection.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(4)): fast flow, product infused in 19h instead of 22h, patient was hospitalized because it was a significant hyperthermia (41degrees c).The drug used was a antibiotic by intravenously.

• 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: 5311297
• MDR Text Key: 33892352
• Report Number: 9610825-2015-00638
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2015,12/01/2015

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: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: N/A
• Device Catalogue Number: 4540008
• Device Lot Number: 15B08GE221
• 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: 12/18/2015
• Distributor Facility Aware Date: 12/01/2015
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2015
• Initial Date Manufacturer Received: 12/01/2015
• Initial Date FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2015
• 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
• Patient Outcome(s): Hospitalization