MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CRIT-LINE BLOOD CHAMBER

Catalog Number CL10021021

Device Problems Leak/Splash (1354); Connection Problem (2900)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/21/2014

Event Type  malfunction  

Event Description

The hemodialysis clinic mgr reported that the crit-line leaked near the end of the treatment, which was successfully completed using this same device.The leak was at the connection to the dialyzer, but the connection had not seemed cross-threaded or loose.Blood dripped down the dialyzer and the hansen connectors.The pt lost less than 10 ml of blood, was unharmed, and did not require any medical intervention.He left the unit alert and oriented, with stable vital signs, ambulatory with his cane.The complainant stated she thinks the cause of the event might be that the crit-line material became flexible once it warmed up from the pt's blood.Therefore, she now has the staff give another twist to tighten the connection about a half an hour into each treatment, and she has had no further incidents.

Manufacturer Narrative

The device has not been returned for physical eval.A plant investigation is in progress and a supplemental report will be submitted upon completion.

• Brand Name: CRIT-LINE BLOOD CHAMBER
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; kaysville UT
• Manufacturer (Section G): HEMA METRICS; 695 north, 900 west; kaysville UT 84037
• Manufacturer Contact: tanya taft, rn, cnor ; 920 winter street; waltham, MA 02451 ; 7816999751
• MDR Report Key: 4239711
• MDR Text Key: 20976130
• Report Number: 2937457-2014-03061
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935958
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CL10021021
• Device Lot Number: 14051303
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BICARB; UNK DIALYZER; ACID; HEMODIALYSIS MACHINE; BLOODLINE; SALINE