MAUDE Adverse Event Report: B. BRAUN EASY PUMP; ELASTOMERIC PUMP

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Diarrhea (1811); Overdose (1988); Loss of consciousness (2418); Sleep Dysfunction (2517); Test Result (2695)

Event Date 01/01/2017

Event Type  No Answer Provided  

Event Description

(b)(6) took a call last week from a woman whose husband has pancreatic cancer and was on 5-fu continuous infusion.He started the infusion on a tuesday and it was supposed to last for a full week.Sometime between friday night and saturday the contents of the whole infusion had been infused.The patient was very sleepy on saturday and sunday and had terrible diarrhea.Even though the infusion was empty, they waited until his doctor's appointment on tuesday to report it.The doctor treated the 5-fu overdose with iv hydration but did not give uridine triacetate.The patient has not fully recovered from this incident, and his blood counts are low.I believe the drug was infused via an elastomeric pump from what the wife was describing.She said this is the type of pump that medicare would cover.He had used the elastomeric pump for previous infusions and had never had a problem.It sounded like the doctor reported the pump malfunction back to the pump manufacturer.She said it would be ok to contact her if any additional details are needed.I spoke with the women today to follow up.I wanted to see how her husband was and if she received any more information from the physicians or nurses.She stated that her husband ended up being hospitalized for 7 days.He went to the outpatient clinic and ended up passing out.He was admitted to the hospital and diagnosed with a pulmonary embolism.He was discharged last week.His blood counts are still not up but he feels so much better.The wife stated that when he is due for their next chemo she will not accept home infusion and will drive every day the 16 miles to the clinic.She is going to e-mail me the name of the pump.She said it was a braun pump "with a sensor on the chest" and "no safety valve." the doctors told her maybe he laid on the tube and the heat caused the malfunction.(b)(6).

• Brand Name: EASY PUMP
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): B. BRAUN
• MDR Report Key: 6450797
• MDR Text Key: 71581811
• Report Number: MW5068815
• Device Sequence Number: 1
• Product Code: MEB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 01/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1