MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. LOW VOLUME PRE-PUMP BLOODLINE (12/CS); SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Model Number	03-2692-6
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
It was reported to fresenius that the low volume pre-pump bloodlines were used for treatment with a fresenius 2008 hemodialysis (hd) machine when the venous chamber filled with blood and they "tried to remove it but were unsuccessful." additional information was requested, however a response was not received.The patient's estimated blood loss (ebl) was not provided.It was not stated during initial reporting that the patient experienced a serious injury, adverse event, or required medical intervention as a result of the reported issue.No parts were returned to the manufacturer for a physical evaluation.
Additional Manufacturer Narrative
Correction: b5 plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).The customer sent a photo where air can be observed at the bottom of the venous chamber; therefore, the alleged incident was confirmed with the photo received.However, with this photo it is not possible to identify any defect in the venous chamber that could be related to the alleged malfunction or identify how the failure mode was generated since the complaint product sample was not provided for physical evaluation.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The investigation into the cause of the reported problem was confirmed.
Event or Problem Description
It was reported to fresenius that the low volume pre-pump bloodlines were used for treatment with a fresenius 2008 hemodialysis (hd) machine when the venous chamber filled with blood and they "tried to remove it but were unsuccessful." upon follow-up, it was reported that the patient did not experience an adverse event, serious injury, or require medical intervention as a result of the reported issue.The patient did not experience blood loss and they were able to continue treatment without issue.No parts were returned to the manufacturer for a physical evaluation.

• Brand Name: LOW VOLUME PRE-PUMP BLOODLINE (12/CS)
• 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; 1100 e, military hwy, suite c; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 14654425
• Report Number: 0008030665-2022-00659
• Device Sequence Number: 11972262
• Product Code: FJK
• UDI-Device Identifier: 00840861100262
• UDI-Public: 00840861100262
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K001107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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 Model Number: 03-2692-6
• Device Catalogue Number: 03-2692-6
• 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: 05/16/2022
• Supplement Date Received by Manufacturer: 07/08/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 07/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 2008 HEMODIALYSIS (HD) MACHINE; FRESENIUS 2008 HEMODIALYSIS (HD) MACHINE
• Patient Sex: Unknown