MAUDE Adverse Event Report: GAMBRO LUNDIA AB PRISMAFLEX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number PRISMAFLEX CONTROL UNIT

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Following a preventive maintenance (pm) the filter set could not be loaded on the machine as the pressure pods would not stay engaged in the housing.Trouble shooting revealed the four pressure pod sealing cones were not put on the pressure pods following the pm.A patient in the icu was transferred to another hospital in order to receive continuous renal replacement therapy.Reportedly, there were no specific detrimental effects as a result of the treatment interruption and delay.

• Brand Name: PRISMAFLEX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): GAMBRO LUNDIA AB; box 10101; lund SE-22 010; SW SE-22010
• Manufacturer Contact: anja sandberg ; box 10101; lund ; SW ; 46169381
• MDR Report Key: 5796893
• MDR Text Key: 49637534
• Report Number: 9616026-2016-00009
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K110823
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRISMAFLEX CONTROL UNIT
• Device Catalogue Number: 107493
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other