MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, 14V LI-ION BATTERY CLIP SET; VENTRICULAR (ASSIST) BYPASS

Model Number	2865
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported the 14 v batteries and battery clips were submerged while the patient was showering in the hospital.There were no alarms and no patient consequences.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was communicated on (b)(6) 2024 that a shower bag was in use and was used appropriately.The system controller remained in use as it did not get wet.The patient did not experience any adverse effects.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of fluid ingress issue could not be confirmed through this evaluation.It was reported by the patient that equipment was in contact with water during a shower.14v battery clip (lot # 8313740) was replaced and returned to the local office in japan.Additional information reported the 14v battery clip will not be returned due to shipping regulation.It was reported the patient did not experience any adverse effect.A root cause that led to the fluid ingress issue could not be determined.The complaint does not meet the requirement of the investigation procedure for a review of the device history records.Heartmate 3 patient handbook rev c, cautions the users to ¿call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment.Your hospital contact can check the equipment and order replacements, if needed.Do not try to repair anything yourself.¿ under section 5, ¿alarms and troubleshooting¿ all alarm conditions are addressed.Under section 2, ¿the system controller self test¿, the system controller self test is loud and bright.All of the lights, symbols, and sounds come on and ¿self test¿ appears on the screen.Under section 8, equipment storage and care, general cleaning guidelines for all equipment.Use a damp cloth to clean exterior surfaces of the system components, as needed.Water, with or without a mild dish soap, may be used as a surface cleaner.Warning: do not allow water to penetrate into the interior of the equipment.Do not immerse equipment in water or liquid.Immersion in water or liquid may cause the pump to stop.Heartmate 3 instructions for use rev a, under section f, safety checklists, replace any equipment or system component that appears damaged or worn.Under section 8, equipment storage and care, general cleaning guidelines for all equipment.Use a damp cloth to clean exterior surfaces of the system components, as needed.Water, with or without a mild dish soap, may be used as a surface cleaner.Warning: do not allow water to penetrate into the interior of the equipment.Do not immerse equipment in water or liquid.Immersion in water or liquid may cause the pump to stop.No further information was provided.The manufacturer is closing the file on this event.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of fluid ingress in the 14v li-ion battery clip was unable to be confirmed.The 14v li-ion battery clip, lot number 8313740, was returned for analysis and passed all functional testing operating as intended.Provided information stated the 14v batteries and clips were submerged while the patient was showering.The patient did not experience any adverse effects.A root cause for the reported event could not be conclusively determined through this evaluation.The complaint does not meet the requirement of the investigation procedure for a review of the device history records.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.A, and the heartmate 3 patient handbook, rev.C are currently available.The current revision of the ifu and patient handbook can be found on the eifu page of the abbott website.The heartmate 3 patient handbook section 5, ¿alarms and troubleshooting¿ all alarm conditions are addressed.The heartmate 3 patient handbook section 8, ¿equipment storage and care¿, and the heartmate 3 ifu section 8 ¿equipment storage and care¿, outlines general cleaning guidelines for all equipment.Use a damp cloth to clean exterior surfaces of the system components, as needed.Water, with or without a mild dish soap, may be used as a surface cleaner.Do not allow water to penetrate the interior of the equipment.Do not immerse equipment in water or liquid.Immersion in water or liquid may cause the pump to stop.The heartmate 3 ifu section f, safety checklists, replace any equipment or system component that appears damaged or worn.Heartmate 3 patient handbook caution users to call their hospital contact if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE®, 14V LI-ION BATTERY CLIP SET
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19975550
• Report Number: 2916596-2024-05231
• Device Sequence Number: 17911115
• Product Code: DSQ
• UDI-Device Identifier: 00813024010715
• UDI-Public: (01)00813024010715(10)8313740(11)220211
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/12/2026

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: Lay User/Patient
• Device Model Number: 2865
• Device Catalogue Number: 2865
• Device Lot Number: 8313740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Supplement Date Received by Manufacturer: 09/05/2024; 10/31/2024; 02/05/2026
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 09/23/2024; 11/15/2024; 02/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Sex: Male
• Patient Weight: 25 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian