MAUDE Adverse Event Report: PENTEC HEALTH PROTEIN BAG; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number DIAMAX110E

Device Problems Display or Visual Feedback Problem (1184); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

The customer contacted baxter's service center regarding a leak which occurred on the home choice (hc) during use during initial drain.The technical service representative (tsr) asked the home patient (hp) if they were connected.The hp stated that he was connected, but that he had disconnected and turned the hc off.The hp stated that he then turned the hc on and it was back to initial drain.The tsr had the hp cycle the power and make sure the clamps were closed.The hc alarmed "power restored/ drain".The tsr reviewed that the drain volume was equal to 1ml.The tsr assisted the hp with ending therapy and getting the set out.The tsr recommended that the hp start over with new supplies.The tsr asked the hp the product code and lot number on the bag that was leaking and the hp stated the bag he had was a protein bag, and that the bag was from pentec health.There was patient involvement but no patient injury or medical intervention indicated at the time of the initial report.(b)(6).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: PROTEIN BAG
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): PENTEC HEALTH
• MDR Report Key: 17524089
• MDR Text Key: 321134553
• Report Number: MW5131036
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/29/2012

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?: No
• Device Model Number: DIAMAX110E
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1