MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. COMBI SET; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number 03-2622-3

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

The buyer for a hemodialysis (hd) user facility reported to fresenius customer service (cs) that a combi set blood leak occurred during a patient's hd treatment.The buyer was inquiring about replacing their unused combi sets from this lot.Few details were obtained via follow up with a nurse from the user facility.The nurse confirmed there was a bloodline blood leak, but could not provide specific event details.The nurse was unable to recall the date of the event, or the patient involved.It was believed that the leak was coming from the portion of the bloodline tubing close to where the device is connected to the patient.Reportedly, there were no adverse effects experienced by the patient and medical intervention was not required as a result of the event.The nurse stated the patient's treatment was able to be completed after they were re-setup with new supplies.The device was discarded immediately after use and was not available to be returned for evaluation.At this time, no further information has been provided.

Manufacturer Narrative

Additional information: plant investigation: as the device was not returned to the manufacturer, a physical evaluation could not be performed.A batch records review was conducted by the manufacturer for the reported lot.There were no non-conformances or abnormalities identified during the manufacturing process which could be associated with the reported event.The entire lot has been sold and distributed.In addition, a device history review was performed and confirmed that the results of the in-progress and final quality control (qc) testing met all requirements.The lot met all specifications for release.A product history review did not reveal a probable cause for the customer complaint.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.

Event Description

The buyer for a hemodialysis (hd) user facility reported to fresenius customer service (cs) that a combi set blood leak occurred during a patient's hd treatment.The buyer was inquiring about replacing their unused combi sets from this lot.Few details were obtained via follow up with a nurse from the user facility.The nurse stated that there was a bloodline blood leak, but could not provide specific event details.The device was discarded immediately after use and was not available to be returned for evaluation.Additional details were later provided by the nurse from the user facility.Despite initial reports of a blood leak occurring, after further investigation, the nurse discovered from staff that the leak occurred prior to treatment initiation.The closed circuit was still being primed with saline when the leak occurred.Per the nurse, saline was observed leaking from the tubing of the combi set, below where the bloodline connects to the patient.There were no reports of visible damage (e.G.A pinhole or cut) at the site of the leak.After the leak was identified, the machine was re-setup with new supplies.The patient was put on the machine after the lines were successfully primed, and they completed their treatment with no further issues.

• Brand Name: COMBI SET
• Type of Device: SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa 88780 ; MX 88780
• MDR Report Key: 10268033
• MDR Text Key: 200235334
• Report Number: 8030665-2020-00973
• Device Sequence Number: 1
• Product Code: FJK
• UDI-Device Identifier: 00840861100231
• UDI-Public: 00840861100231
• Combination Product (y/n): N
• PMA/PMN Number: K962081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 03-2622-3
• Device Catalogue Number: 03-2622-3
• Device Lot Number: 20AR01099
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1