MAUDE Adverse Event Report: GAMBRO RENAL / GAMBRO ROSTOCK GMBH PRISMAFLEX DRAINAGE BAG

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

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

Event Date 10/18/2018

Event Type  malfunction  

Event Description

Rn noted that crrt was not running properly, weights were off on the scales. Rn noted that the effluent bag had a tiny hole in it and it was spraying a small jet of effluent body fluid out of the bag. Rn did not get splashed. Rn replaced the effluent bag, which also had a hole in it.

• Brand Name: PRISMAFLEX DRAINAGE BAG
• Type of Device: PRISMAFLEX DRAINAGE BAG
• Manufacturer (Section D): GAMBRO RENAL / GAMBRO ROSTOCK GMBH
• MDR Report Key: 7999997
• MDR Text Key: 125104254
• Report Number: MW5080796
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Patient Treatment Data

Date Received: 10/23/2018 Patient Sequence Number: 1