MAUDE Adverse Event Report: FRESENIUS MED CARE REYNOSA PLANT COMBI SET

Catalog Number 03-2622-3

Device Problem Fluid/Blood Leak (1250)

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

Event Date 09/22/2014

Event Type  malfunction  

Event Description

A hemodialysis inpatient user facility has reported that during treatment a blood leak occurred.The tubing set was reported to have moisture in it and pin holes.The pt blood loss was due to blood escaping through the pin holes in the tubing set.The pt's estimated blood loss was unk.Additional attempts have been made with no additional info provided.Prophylactic antibiotics were administered as a precaution.The pt had no adverse effects and no med intervention was required.Sample has been discarded.

Manufacturer Narrative

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

• Brand Name: COMBI SET
• Manufacturer (Section D): FRESENIUS MED CARE REYNOSA PLANT; reynosa ; MX
• Manufacturer (Section G): REYNOSA PLANT; erika de reynosa s.a. de c.v.; mike allen 1331 parque industrial; reynosa, tamaulipas CP 8 8780; MX CP 88780
• Manufacturer Contact: dianne chin ; 920 winter st; waltham, MA 02451-1457 ; 7816999105
• MDR Report Key: 4350195
• MDR Text Key: 5223128
• Report Number: 8030665-2014-00913
• 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: 11/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2017
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 14DR01259
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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: 62 YR
• Patient Weight: 114