MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA CRIT-LINE DISPOSABLE BLOOD CHAMBER; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Catalog Number 10021021

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Nonstandard Device (1420)

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

Event Date 05/31/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The lot number and sample are not available.The plant investigation is in progress and a supplemental medwatch will be submitted will additional relevant information.

Event Description

During medical record review for unrelated events, it was learned the crit-line blood chamber leaked.Estimated blood loss was less than 100ml.During follow up with the initial reporter, the leak occurred from the area that connects to the arterial end of the dialyzer.No medical intervention was required.No sample is available.It was discarded.The patient continues on hemodialysis.

Manufacturer Narrative

The device was not returned to the manufacturer for physical evaluation, and the lot number was not provided.Therefore, the failure mode cannot be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

• Brand Name: CRIT-LINE DISPOSABLE BLOOD CHAMBER
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; 4040 nelson ave.; concord CA 94520
• Manufacturer (Section G): CONCORD PLANT; 4040 nelson ave.; concord CA 94520
• Manufacturer Contact: tanya taft ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5484430
• MDR Text Key: 39934590
• Report Number: 2937457-2016-00234
• 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: company representative,health
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10021021
• Other Device ID Number: 00840861100842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1047-2015
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 66