MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA FRESENIUS COMBISET 2008, NO HEPARIN LINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number 03-2742-9

Device Problem Torn Material (3024)

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

Event Date 06/30/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).No parts were returned to the manufacturer for physical evaluation.The plant investigation is in process.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

A user facility reported that air was noticed coming from the arterial chamber during a hemodialysis treatment.The blood lines were checked and there was no evidence of a loose connection.The nurse removed the circuit and did not rinse back the patient's blood.The patient's estimated blood loss (ebl) was noted as being approximately 250cc.The patient was restrung with a new setup on a new machine and was able to complete treatment with no adverse effects.The complaint device was not available for evaluation by the manufacturer as it was discarded by the user facility.Follow-up information was received which revealed that the bloodline appeared to have a slash in the tubing as though it had been cut with a sharp instrument.

Manufacturer Narrative

The reported complaint was not confirmed as the complaint device was not available for manufacturer evaluation.As such, a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.A records review was performed on the reported lot.An investigation of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances identified during the manufacturing process which could be associated with the reported event.In addition, the batch record review confirmed the labeling, material, and process controls were within specification.The lot passed all release criteria.Review of the batch production record (bpr) did not reveal a probable cause for the customer complaint.

• Brand Name: FRESENIUS COMBISET 2008, NO HEPARIN LINE
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa, tamaulipas cp 88780 ; MX 88780
• Manufacturer Contact: thomas johnson ; 920 winter st.; waltham, MA 02451 ; 7816999000
• MDR Report Key: 5831724
• MDR Text Key: 51495031
• Report Number: 8030665-2016-00382
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 03-2742-9
• Device Lot Number: 16CR01452
• Other Device ID Number: 00840861100309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2016
• 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: 77 YR
• Patient Weight: 115