MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. 5008X STANDARD HDF BLOODLINE; SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Catalog Number	03-5100-7
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Plant investigation: the sample was not returned to the manufacturer for physical evaluation.However, several photos were provided by the user facility.Based on the provided photos, it can be observed that a leak occurred at the arterial pressure dome due to incorrect assembly.An internal inventory search was performed to verify product availability for companion samples at distribution centers.The entire lot has been sold and distributed.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.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.Based on the received photos, the reported failure was able to be confirmed.
Event or Problem Description
A user facility charge nurse (cn) reported that a fresenius 5008x bloodline ruptured at the arterial pressure dome during a patient¿s hemodialysis (hd) treatment.The cn stated there were air detected in lines alarms going off approximately one to two hours into the patient's treatment, and they could not figure out what was causing it.The cn said the arterial pressure dome is hidden from plain view, but they eventually noticed blood trickling from behind the component.The patient's blood was reinfused, and they were re-setup with new supplies on the same machine.Upon closer inspection of the bloodline, a tiny slit was observed on the arterial pressure dome.No physical damage was noted on the bloodline prior to set-up, and there were no other issues or alarms leading up to the leak.The cn also confirmed there were no changes in the patient's blood flow rate (bfr) prior to the rupture occurring.The patient¿s estimated blood loss (ebl) due to the leak was 30 ml.The cn confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient did not complete their full treatment; they asked to end it early due to the delay caused by the leak.The complaint device was not available to be returned for evaluation as it was reportedly discarded.However, photos of the device were provided for review.
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Event or Problem Description
A user facility charge nurse (cn) reported that a fresenius 5008x bloodline ruptured at the arterial pressure dome during a patient¿s hemodialysis (hd) treatment.The cn stated there were air detected in lines alarms going off approximately one to two hours into the patient's treatment, and they could not figure out what was causing it.The cn said the arterial pressure dome is hidden from plain view, but they eventually noticed blood trickling from behind the component.The patient's blood was reinfused, and they were re-setup with new supplies on the same machine.Upon closer inspection of the bloodline, a tiny slit was observed on the arterial pressure dome.No physical damage was noted on the bloodline prior to set-up, and there were no other issues or alarms leading up to the leak.The cn also confirmed there were no changes in the patient's blood flow rate (bfr) prior to the rupture occurring.The patient¿s estimated blood loss (ebl) due to the leak was 30 ml.The cn confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported event.The patient did not complete their full treatment; they asked to end it early due to the delay caused by the leak.The complaint device was not available to be returned for evaluation as it was reportedly discarded.However, photos of the device were provided for review.

• Brand Name: 5008X STANDARD HDF BLOODLINE
• Common Device Name: 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
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 19899853
• Report Number: 0008030665-2024-00683
• Device Sequence Number: 6557242
• Product Code: FJK
• UDI-Device Identifier: 00840861102365
• UDI-Public: 00840861102365
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K231534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Catalogue Number: 03-5100-7
• Device Lot Number: 24CR01803
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/02/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRESENIUS 5008X MACHINE.; FRESENIUS 5008X MACHINE.; FRESENIUS OPTIFLUX DIALYZER.; FRESENIUS OPTIFLUX DIALYZER.
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 88 KG