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

Model Number N/A

Device Problem Infusion or Flow Problem (2964)

Patient Problem Chest Pain (1776)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device history record (dhr):- reviewed the dhr for batch 20e11ge291, there is no abnormality and no such defect detected at in process and at final control inspection.Sample evaluation: received one easypump ii lt 400-80-s without original packaging.The batch number on the big bottom cap of the sample was 20e11ge291.The sample was reported with contaminated with cytotoxic drug.As received condition, clamp clip of received sample was not clamped.Patient connector was not connected to the closing cone.Flow rate test: the sample was subjected to flow rate test (etr: ltca-bw5b2x).The flow rate deviation from nominal flow rate for complaint sample were -4.82% from nominal flow rate.The flow rate result was within specification ¿15% deviation from nominal flow rate.Root cause analysis: per customer description, the pump were expected to finish after 46 hours.However, the customer mentioned that it was empty after 12 hours earlier.According to ifu, the minimal fill volume of the pump was 240ml and if the pump was filled with 240ml, with the nominal flow rate of 5ml/hr, the approximate delivery time for the pump is 48 hours.However, according to the customer description, the pump was expected to empty after 46 hours.If customer filled in the pump with 230ml and expected it to empty after 46 hours, it was below the defined minimal infusion time and filling volume of the pump according to ifu.Conclusion: the pump was expected to infuse after 46 hours which was below the allowable minimal infusion time of the pump according to ifu.Furthermore, the flow rate of received sample was within specification.

Event Description

As reported by the user facility (translation of user facility information by bbm sales organization in (b)(6)): overinfusion patient started on 5fu injection on 25th 1pm.Expected to finish after 46 hours.But infusion finished 12 hours early.Patient reported this to pvt day care on 27th morning.He had chest pain.Ecg was done and report was normal normal.Patient left for home.He has this chemotherapy cycle every 21days.(b)(6) hospital, (b)(6)).Dr.(b)(6).

• 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: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 11059743
• MDR Text Key: 223779613
• Report Number: 9610825-2020-00360
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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: 4540022
• Device Lot Number: 20E11GE291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2020
• 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