MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE CUSTOM COMBI SET; FJK

Catalog Number 03-2722-9

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 08/28/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that at the end of treatment, a blood leak occurred while blood was being returned to patient.The tech immediately clamped the line.The remainder of blood in the line was not returned to patient.Estimated blood loss was 150ml.The patient has no adverse effects and no medical intervention was required.Sample available.

Manufacturer Narrative

Plant investigation has not yet been completed.A follow up report will be filed upon completion of the investigation.

• Brand Name: CUSTOM COMBI SET
• Type of Device: FJK
• Manufacturer (Section D): FRESENIUS MEDICAL CARE; reynosa plant, reynosa ; MX
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; brecha e99 sur; parque; industrial reynos, bldg. ii; cd, reynosa, tamaulipas 8878 0; MX 88780
• Manufacturer Contact: dianne chin ; 920 winter st; waltham, MA 02451-1457 ; 7816999105
• MDR Report Key: 4107378
• MDR Text Key: 4836881
• Report Number: 8030665-2014-00740
• Device Sequence Number: 1
• Product Code: FJK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: 03-2722-9
• Device Lot Number: 14JR01162
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 75 YR