MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. EASYPUMP; PUMP, INFUSION, ELASTOMERIC

Model Number LT 270-54-S

Device Problem Fluid/Blood Leak (1250)

Patient Problems Underdose (2542); Missed Dose (2561)

Event Date 12/06/2018

Event Type  Injury  

Event Description

Pt was attached with a braun easy pump elastomeric infusion pump 5ml/hr device to deliver 5fu over 48 hours at approx 13:19 on (b)(6) 2018.(pump lot: 17a10ge56r, exp: 01/01/2022) pt reported to clinic at 09:15 on (b)(6) 2018 stating the pump had leaked.The pt reported he had gone to bed around 2100 on (b)(6), awoken around 0000 (b)(6) with no issues, at which time he went back to bed.Upon waking at approx 0800 he noticed his pajamas were wet but his bed and wire were not.He clamped the device, took a shower and washed those clothes separately as he was taught in case of chemo spills.While in the clinic, rn and rph checked the device while still attached to the pt, it was attached correctly.No line issues or line leaks were found.Upon inspection, it was clear that the black carrying bag, the device was in, was soaked with drug.We removed it from the pt and took it into the pharmacy hood for further investigation.The device itself was soaked, the plastic "chemo" bag it was in, had a puddle of fluid in it.The inner bladder of the device appeared to have no fluid in it but was significantly distended, as if full or air.We consulted md who advised us to make a new pump with the approximate rest of the dose to be delivered over the next 28 hours, as this was the closest he could get to delivering the pt, his correct dose.We have appropriately contained the device and associated materials in chemo waste bags and it is available for further investigation.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 8147037
• MDR Text Key: 130028924
• Report Number: MW5081980
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: LT 270-54-S
• Device Catalogue Number: B4540018-02
• Device Lot Number: 17A10GE56R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 75