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

Device Problems Material Puncture/Hole (1504); Device Displays Incorrect Message (2591)

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

Event Date 04/29/2012

Event Type  Injury  

Event Description

On (b)(6) 2012, product surveillance contacted the caregiver (cg) regarding a system error 2240 that occurred on (b)(6) 2012.The cg stated that there was a hole in the final bag, which was a protein bag, made by pentec health which caused the system error 2240.The cg stated that they did have any form of samples and did not have a lot number for the bag.The cg stated that the home patient (hp) finished therapy manually that night.There was no patient injury or medical intervention reported.001406005.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: 17531881
• MDR Text Key: 321144005
• Report Number: MW5138792
• 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: 05/03/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1