MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 SPECIMEN COLLECTION 4-PORT MANIFOLD; APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Catalog Number	0702020001
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device discarded by customer.
Event or Problem Description
It was reported by a circulating nurse at the user facility that a manifold was likely to have clogged causing loss of suction during a pelvic sarcoma procedure.The customer indicated that to her knowledge, only blood was being extracted, no other material.It was reported that during the case the surgeon was using about 1 liter of blood per minute, with a final estimated blood loss was 18l.The neptune device that the manifold works in conjunction with almost completely stopped providing suction at one point during the procedure when the abdomen was filling up with blood.The customer tried removing and replacing the manifold several times as they felt is was filing up.The customer was using only the 20l canister with 2 suction lines coming from the top 2 manifold ports, both going to the field.The initial suction setting was "medium," when the surgeon signaled to circulating nurse that the device was clogging she turned it up to "high" but the clogging persisted.The customer continued trying to remove and reinsert the manifold which would work for a short time as the suction would get better for a while, but would eventually get worse again.The procedure was completed successfully with no known impact or adverse consequences to the patient that were reported with this event.

• Brand Name: NEPTUNE 2 SPECIMEN COLLECTION 4-PORT MANIFOLD
• Common Device Name: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7330042
• Report Number: 0001811755-2018-00496
• Device Sequence Number: 145225
• Product Code: JCX
• UDI-Device Identifier: 37613154733225
• UDI-Public: (01)37613154733225
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K132671
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2018

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 Catalogue Number: 0702020001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 03/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1